ELARIS EM-I: A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01620528
Collaborator
(none)
872
3
40.2
Study Details
Study Description
Brief Summary
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
872 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Study Start Date
:
May 22, 2012
Actual Primary Completion Date
:
Nov 14, 2014
Actual Study Completion Date
:
Sep 28, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Elagolix 150 mg QD Elagolix 150 mg once daily (QD) for the 6-month Treatment Period |
Drug: elagolix
oral tablet
Other Names:
|
| Experimental: Elagolix 200 mg BID Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period |
Drug: elagolix
oral tablet
Other Names:
|
| Placebo Comparator: Placebo Placebo BID for the 6-month Treatment Period |
Other: placebo
oral tablet
|
Outcome Measures
Primary Outcome Measures
- Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) [At Month 3 of the Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) [At Month 3 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Secondary Outcome Measures
- Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores [Baseline, Month 3 of the Treatment Period]
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
- Change From Baseline to Month 6 in DYS [Baseline, Month 6 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 6 in NMPP [Baseline, Month 6 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Month 3 of Treatment Period]
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Month 6 of Treatment Period]
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Change From Baseline to Month 3 in Dyspareunia (DYSP) [Baseline, Month 3 of Treatment Period]
The DYSP pain scale ranges from 0 (absent) to 3 (severe).
- Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) [Baseline, Month 3 of Treatment Period]
Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Percentage of Responders at Month 1 Based on Daily Assessment of DYS [At Month 1 of the Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 2 Based on Daily Assessment of DYS [At Month 2 of the Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 4 Based on Daily Assessment of DYS [At Month 4 of the Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 5 Based on Daily Assessment of DYS [At Month 5 of the Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 6 Based on Daily Assessment of DYS [At Month 6 of the Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 1 Based on Daily Assessment of NMPP [At Month 1 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 2 Based on Daily Assessment of NMPP [At Month 2 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 4 Based on Daily Assessment of NMPP [At Month 4 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 5 Based on Daily Assessment of NMPP [At Month 5 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 6 Based on Daily Assessment of NMPP [At Month 6 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 1 for DYSP [At Month 1 of the Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 2 for DYSP [At Month 2 of the Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 4 for DYSP [At Month 4 of the Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 5 for DYSP [At Month 5 of the Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Percentage of Responders at Month 6 for DYSP [At Month 6 of the Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
- Change From Baseline to Month 1 in Mean Pain Score for DYS [Baseline, Month 1 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 2 in Mean Pain Score for DYS [Baseline, Month 2 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 3 in Mean Pain Score for DYS [Baseline, Month 3 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 4 in Mean Pain Score for DYS [Baseline, Month 4 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 5 in Mean Pain Score for DYS [Baseline, Month 5 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 1 in Mean Pain Score for DYS [Baseline, Month 1 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 2 in Mean Pain Score for DYS [Baseline, Month 2 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 3 in Mean Pain Score for DYS [Baseline, Month 3 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 4 in Mean Pain Score for DYS [Baseline, Month 4 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 5 in Mean Pain Score for DYS [Baseline, Month 5 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 6 in Mean Pain Score for DYS [Baseline, Month 6 of Treatment Period]
The DYS pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 1 in Mean Pain Score for NMPP [Baseline, Month 1 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 2 in Mean Pain Score for NMPP [Baseline, Month 2 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 3 in Mean Pain Score for NMPP [Baseline, Month 3 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 4 in Mean Pain Score for NMPP [Baseline, Month 4 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 5 in Mean Pain Score for NMPP [Baseline, Month 5 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP [Baseline, Month 1 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP [Baseline, Month 2 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP [Baseline, Month 3 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP [Baseline, Month 4 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP [Baseline, Month 5 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP [Baseline, Month 6 of Treatment Period]
The NMPP pain scale ranges from 0 (none) to 3 (severe).
- Change From Baseline to Month 1 in Mean Pain Score of DYSP [Baseline, Month 1 of Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
- Change From Baseline to Month 2 in Mean Pain Score of DYSP [Baseline, Month 2 of Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
- Change From Baseline to Month 4 in Mean Pain Score of DYSP [Baseline, Month 4 of Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
- Change From Baseline to Month 5 in Mean Pain Score of DYSP [Baseline, Month 5 of Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
- Change From Baseline to Month 6 in Mean Pain Score of DYSP [Baseline, Month 6 of Treatment Period]
The DYSP pain scale ranged from 0 (absent) to 3 (severe).
- Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Month 1 of Treatment Period]
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Month 2 of Treatment Period]
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Month 4 of Treatment Period]
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Month 5 of Treatment Period]
Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
- Response to Patient Global Impression of Change (PGIC) at Month 1 [Month 1 of Treatment Period]
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
- Response to PGIC at Month 2 [Month 2 of Treatment Period]
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
- Response to PGIC at Month 3 [Month 3 of Treatment Period]
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
- Response to PGIC at Month 4 [Month 4 of Treatment Period]
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
- Response to PGIC at Month 5 [Month 5 of Treatment Period]
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
- Response to PGIC at Month 6 [Month 6 of Treatment Period]
The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
- Change From Baseline to Month 1 in NRS Scores [Baseline, Month 1 of Treatment Period]
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
- Change From Baseline to Month 2 in NRS Scores [Baseline, Month 2 of Treatment Period]
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
- Change From Baseline to Month 4 in NRS Scores [Baseline, Month 4 of Treatment Period]
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
- Change From Baseline to Month 5 in NRS Scores [Baseline, Month 5 of Treatment Period]
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
- Change From Baseline to Month 6 in NRS Scores [Baseline, Month 6 of Treatment Period]
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
- Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) [Baseline, Month 1 of Treatment Period]
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
- Change From Baseline to Month 3 in the Pain Domain of the EHP-30 [Baseline, Month 3 of Treatment Period]
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
- Change From Baseline to Month 6 in the Pain Domain of the EHP-30 [Baseline, Month 6 of Treatment Period]
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
- Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 [Baseline, Month 1 of Treatment Period]
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
- Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 [Baseline, Month 3 of Treatment Period]
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
- Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 [Baseline, Month 6 of Treatment Period]
The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
- Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Month 1 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Month 2 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Month 3 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Month 4 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Month 5 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Month 6 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Month 1 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Month 2 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Month 3 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Month 4 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Month 5 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Month 6 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Month 1 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Month 2 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Month 3 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Month 4 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Month 5 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Month 6 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Month 1 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Month 2 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Month 3 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Month 4 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Month 5 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Month 6 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
- Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Month 1 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Month 2 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Month 3 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Month 4 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Month 5 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Month 6 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Month 1 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Month 2 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Month 3 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Month 4 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Month 5 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Month 6 of Treatment Period]
The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
- Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period [Up to Month 6 of Treatment Period]
- Number of Days of Hospitalization [Up to Month 6 of Treatment Period]
- Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type [Up to Month 6 of Treatment Period]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
-
Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
-
Agrees to use required birth control methods during the entire length of participation in the study.
-
Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1
Exclusion Criteria:
-
Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
-
Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
-
Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
-
Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
-
Subject has a history of osteoporosis or other metabolic bone disease.
-
Subject has a current history of undiagnosed abnormal genital bleeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Rachel Duan, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01620528
Other Study ID Numbers:
- M12-665
First Posted:
Jun 15, 2012
Last Update Posted:
Sep 18, 2018
Last Verified:
Mar 1, 2017
Keywords provided by AbbVie (prior sponsor, Abbott)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | After completing the Treatment Period, participants (who were eligible and provided consent) entered a separate continuous-use extension study (Study M12-667, NCT01760954). |
|---|---|
| Pre-assignment Detail | Participants who prematurely discontinued from study drug and those who declined to participate in or who did not qualify for the continuous-use extension study, except for those who became pregnant, could elect to enter the Post-Treatment Follow-Up (PTFU) Period within this study for up to 12 additional months. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo twice daily (BID) for the 6-month Treatment Period | Elagolix 150 mg once daily (QD) for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Period Title: Treatment Period | |||
| STARTED | 374 | 249 | 249 |
| COMPLETED | 274 | 196 | 183 |
| NOT COMPLETED | 100 | 53 | 66 |
| Period Title: Treatment Period | |||
| STARTED | 68 | 48 | 51 |
| Completed PTFU Month 6 | 46 | 26 | 18 |
| Completed PTFU Month 12 | 2 | 5 | 19 |
| COMPLETED | 48 | 31 | 37 |
| NOT COMPLETED | 20 | 17 | 14 |
Baseline Characteristics
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID | Total |
|---|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period | Total of all reporting groups |
| Overall Participants | 374 | 249 | 248 | 871 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
31.7
(6.35)
|
31.5
(5.99)
|
31.2
(6.33)
|
31.5
(6.24)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
374
100%
|
249
100%
|
248
100%
|
871
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 3 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 373 | 248 | 244 |
| Number [percentage of participants] |
19.6
5.2%
|
46.4
18.6%
|
75.8
30.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 373 | 248 | 244 |
| Number [percentage of participants] |
36.5
9.8%
|
50.4
20.2%
|
54.5
22%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores |
|---|---|
| Description | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Time Frame | Baseline, Month 3 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.09
(0.098)
|
-1.74
(0.120)
|
-2.39
(0.122)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 1 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.155 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 1 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -1.30 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.156 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 288 | 198 | 182 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.44
(0.047)
|
-0.89
(0.057)
|
-1.75
(0.059)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 2 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.074 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 2 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Least Squares Mean |
| Estimated Value | -1.32 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.076 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 288 | 198 | 182 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.31
(0.035)
|
-0.48
(0.043)
|
-0.72
(0.044)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 3 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.056 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 3 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.057 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics |
|---|---|
| Description | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [pills] |
-0.29
(0.032)
|
-0.29
(0.039)
|
-0.55
(0.040)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 4 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.910 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.051 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 4 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.051 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics |
|---|---|
| Description | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 288 | 198 | 182 |
| Least Squares Mean (Standard Error) [pills] |
-0.27
(0.036)
|
-0.35
(0.043)
|
-0.56
(0.045)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 5 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.185 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.056 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 5 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.057 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in Dyspareunia (DYSP) |
|---|---|
| Description | The DYSP pain scale ranges from 0 (absent) to 3 (severe). |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 246 | 171 | 153 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.29
(0.041)
|
-0.39
(0.050)
|
-0.49
(0.052)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 6 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.144 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.065 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 6 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.067 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) |
|---|---|
| Description | Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [pills] |
-0.10
(0.024)
|
-0.07
(0.029)
|
-0.22
(0.029)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 7 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.424 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | 0.03 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.037 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | Ranked secondary efficacy endpoint 7 of 7. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Mean Change |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.038 |
|
| Estimation Comments | ||
| Title | Percentage of Responders at Month 1 Based on Daily Assessment of DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 1 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Number [percentage of participants] |
14.5
3.9%
|
35.1
14.1%
|
44.1
17.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 2 Based on Daily Assessment of DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 2 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 373 | 248 | 244 |
| Number [percentage of participants] |
17.2
4.6%
|
44.8
18%
|
71.3
28.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 4 Based on Daily Assessment of DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 4 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 373 | 248 | 243 |
| Number [percentage of participants] |
21.7
5.8%
|
47.6
19.1%
|
75.3
30.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 5 Based on Daily Assessment of DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 5 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 371 | 247 | 243 |
| Number [percentage of participants] |
24.3
6.5%
|
45.7
18.4%
|
79.0
31.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 6 Based on Daily Assessment of DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 6 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 247 | 243 |
| Number [percentage of participants] |
23.1
6.2%
|
42.1
16.9%
|
75.3
30.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 1 Based on Daily Assessment of NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Number [percentage of participants] |
25.8
6.9%
|
32.3
13%
|
33.9
13.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.103 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 2 Based on Daily Assessment of NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 373 | 248 | 244 |
| Number [percentage of participants] |
32.2
8.6%
|
41.1
16.5%
|
46.3
18.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 4 Based on Daily Assessment of NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 373 | 248 | 243 |
| Number [percentage of participants] |
35.4
9.5%
|
53.2
21.4%
|
63.8
25.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 5 Based on Daily Assessment of NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 371 | 247 | 243 |
| Number [percentage of participants] |
38.3
10.2%
|
49.8
20%
|
62.1
25%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 6 Based on Daily Assessment of NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 247 | 243 |
| Number [percentage of participants] |
34.9
9.3%
|
45.7
18.4%
|
62.1
25%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 1 for DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 1 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 293 | 191 | 176 |
| Number [percentage of participants] |
26.3
7%
|
30.4
12.2%
|
31.8
12.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.306 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.239 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 2 for DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 2 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 287 | 190 | 179 |
| Number [percentage of participants] |
33.1
8.9%
|
33.7
13.5%
|
44.7
18%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.855 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 4 for DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 4 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 278 | 185 | 168 |
| Number [percentage of participants] |
33.1
8.9%
|
44.3
17.8%
|
54.2
21.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 5 for DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 5 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 275 | 183 | 166 |
| Number [percentage of participants] |
35.3
9.4%
|
43.7
17.6%
|
54.8
22.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.061 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Percentage of Responders at Month 6 for DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. |
| Time Frame | At Month 6 of the Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 270 | 187 | 161 |
| Number [percentage of participants] |
33.3
8.9%
|
39.6
15.9%
|
50.3
20.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.126 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Change From Baseline to Month 1 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.33
(0.044)
|
-0.83
(0.054)
|
-0.98
(0.054)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.50 | |
| Confidence Interval |
(2-Sided) 97.5% -0.65 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.070 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 97.5% -0.81 to -0.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.070 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 348 | 232 | 221 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.32
(0.042)
|
-0.96
(0.052)
|
-1.68
(0.053)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.64 | |
| Confidence Interval |
(2-Sided) 97.5% -0.79 to -0.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.067 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.36 | |
| Confidence Interval |
(2-Sided) 97.5% -1.51 to -1.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.068 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.35
(0.043)
|
-1.03
(0.052)
|
-1.73
(0.054)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 97.5% -0.83 to -0.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.068 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.39 | |
| Confidence Interval |
(2-Sided) 97.5% -1.54 to -1.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.069 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 316 | 219 | 198 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.40
(0.045)
|
-1.05
(0.054)
|
-1.72
(0.057)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 97.5% -0.81 to -0.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.071 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.32 | |
| Confidence Interval |
(2-Sided) 97.5% -1.49 to -1.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.072 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 299 | 202 | 191 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.43
(0.045)
|
-1.02
(0.054)
|
-1.84
(0.056)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.59 | |
| Confidence Interval |
(2-Sided) 97.5% -0.75 to -0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.071 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.41 | |
| Confidence Interval |
(2-Sided) 97.5% -1.58 to -1.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.072 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 1 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Least Squares Mean (Standard Error) [percentage change] |
-14.35
(2.079)
|
-38.42
(2.547)
|
-45.35
(2.562)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -24.07 | |
| Confidence Interval |
(2-Sided) 97.5% -31.45 to -16.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.288 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -31.01 | |
| Confidence Interval |
(2-Sided) 97.5% -38.41 to -23.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.299 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 2 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 348 | 232 | 221 |
| Least Squares Mean (Standard Error) [percentage change] |
-13.44
(1.965)
|
-44.23
(2.407)
|
-77.22
(2.460)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | -30.79 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -30.79 | |
| Confidence Interval |
(2-Sided) 97.5% -37.77 to -23.82 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.107 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -63.78 | |
| Confidence Interval |
(2-Sided) 97.5% -70.85 to -56.71 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.148 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 3 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [percentage change] |
-14.80
(2.022)
|
-47.01
(2.451)
|
-79.74
(2.519)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -32.21 | |
| Confidence Interval |
(2-Sided) 97.5% -39.35 to -25.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.177 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -64.94 | |
| Confidence Interval |
(2-Sided) 97.5% -72.19 to -57.68 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.230 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 4 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 316 | 219 | 198 |
| Least Squares Mean (Standard Error) [percentage change] |
-18.08
(2.088)
|
-48.02
(2.519)
|
-79.98
(2.627)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -29.94 | |
| Confidence Interval |
(2-Sided) 97.5% -37.28 to -22.59 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.272 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -61.90 | |
| Confidence Interval |
(2-Sided) 97.5% -69.44 to -54.36 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.356 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 5 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 299 | 202 | 191 |
| Least Squares Mean (Standard Error) [percentage change] |
-18.09
(2.072)
|
-46.72
(2.517)
|
-84.58
(2.595)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -28.63 | |
| Confidence Interval |
(2-Sided) 97.5% -35.96 to -21.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.260 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -66.50 | |
| Confidence Interval |
(2-Sided) 97.5% -73.95 to -59.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.321 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 6 in Mean Pain Score for DYS |
|---|---|
| Description | The DYS pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 288 | 198 | 182 |
| Least Squares Mean (Standard Error) [percentage change] |
-19.21
(2.217)
|
-40.60
(2.681)
|
-79.99
(2.782)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -21.39 | |
| Confidence Interval |
(2-Sided) 97.5% -29.20 to -13.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.479 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -60.78 | |
| Confidence Interval |
(2-Sided) 97.5% -68.77 to -52.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.557 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.16
(0.023)
|
-0.22
(0.028)
|
-0.26
(0.028)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.111 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 97.5% -0.14 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.036 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 97.5% -0.18 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.036 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 348 | 232 | 221 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.26
(0.028)
|
-0.33
(0.035)
|
-0.44
(0.035)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.092 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 97.5% -0.18 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.045 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 97.5% -0.28 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.045 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.32
(0.032)
|
-0.44
(0.039)
|
-0.61
(0.039)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 97.5% -0.23 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.050 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.29 | |
| Confidence Interval |
(2-Sided) 97.5% -0.41 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.050 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 316 | 219 | 198 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.33
(0.034)
|
-0.51
(0.041)
|
-0.72
(0.042)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 97.5% -0.31 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.053 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 97.5% -0.51 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.054 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 299 | 202 | 191 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.34
(0.034)
|
-0.49
(0.041)
|
-0.74
(0.042)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 97.5% -0.27 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.053 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 97.5% -0.52 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.054 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Least Squares Mean (Standard Error) [percentage change] |
-7.51
(1.736)
|
-13.74
(2.131)
|
-15.23
(2.139)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.024 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -6.23 | |
| Confidence Interval |
(2-Sided) 97.5% -12.40 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.748 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -7.72 | |
| Confidence Interval |
(2-Sided) 97.5% -13.90 to -1.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.756 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 348 | 232 | 221 |
| Least Squares Mean (Standard Error) [percentage change] |
-13.81
(2.039)
|
-19.50
(2.501)
|
-27.53
(2.529)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.078 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -5.69 | |
| Confidence Interval |
(2-Sided) 97.5% -12.93 to 1.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.226 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -13.72 | |
| Confidence Interval |
(2-Sided) 97.5% -21.01 to -6.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.249 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 329 | 226 | 213 |
| Least Squares Mean (Standard Error) [percentage change] |
-17.64
(2.204)
|
-26.10
(2.688)
|
-40.13
(2.737)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -8.47 | |
| Confidence Interval |
(2-Sided) 97.5% -16.27 to -0.66 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.475 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -22.49 | |
| Confidence Interval |
(2-Sided) 97.5% -30.38 to -14.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.514 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 316 | 219 | 198 |
| Least Squares Mean (Standard Error) [percentage change] |
-17.94
(2.333)
|
-32.05
(2.837)
|
-48.35
(2.909)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -14.11 | |
| Confidence Interval |
(2-Sided) 97.5% -22.36 to -5.87 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.673 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -30.41 | |
| Confidence Interval |
(2-Sided) 97.5% -38.78 to -22.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.729 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 299 | 202 | 191 |
| Least Squares Mean (Standard Error) [percentage change] |
-19.60
(2.371)
|
-31.15
(2.888)
|
-49.28
(2.954)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -11.55 | |
| Confidence Interval |
(2-Sided) 97.5% -19.94 to -3.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.736 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -29.68 | |
| Confidence Interval |
(2-Sided) 97.5% -38.19 to -21.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.788 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP |
|---|---|
| Description | The NMPP pain scale ranges from 0 (none) to 3 (severe). |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 288 | 198 | 182 |
| Least Squares Mean (Standard Error) [percentage change] |
-18.17
(2.418)
|
-30.55
(2.939)
|
-48.14
(3.019)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -12.37 | |
| Confidence Interval |
(2-Sided) 97.5% -20.92 to -3.83 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.805 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -29.97 | |
| Confidence Interval |
(2-Sided) 97.5% -38.66 to -21.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.868 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in Mean Pain Score of DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 293 | 191 | 176 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.18
(0.032)
|
-0.29
(0.040)
|
-0.22
(0.042)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 97.5% -0.22 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.052 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.488 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 97.5% -0.16 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.053 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in Mean Pain Score of DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 267 | 178 | 165 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.26
(0.038)
|
-0.33
(0.046)
|
-0.38
(0.048)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.252 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 97.5% -0.20 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.060 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.058 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 97.5% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.061 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in Mean Pain Score of DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 231 | 164 | 139 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.27
(0.044)
|
-0.45
(0.053)
|
-0.61
(0.056)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 97.5% -0.34 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.069 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.34 | |
| Confidence Interval |
(2-Sided) 97.5% -0.50 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.071 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in Mean Pain Score of DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 217 | 149 | 131 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.30
(0.047)
|
-0.44
(0.056)
|
-0.57
(0.060)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.060 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 97.5% -0.30 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.073 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 97.5% -0.44 to -0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.076 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in Mean Pain Score of DYSP |
|---|---|
| Description | The DYSP pain scale ranged from 0 (absent) to 3 (severe). |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 203 | 149 | 120 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.29
(0.048)
|
-0.41
(0.057)
|
-0.60
(0.062)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.118 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 97.5% -0.28 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.074 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 97.5% -0.48 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.078 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics |
|---|---|
| Description | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 245 |
| Least Squares Mean (Standard Error) [pills] |
-0.20
(0.028)
|
-0.25
(0.034)
|
-0.32
(0.034)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.313 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 97.5% -0.14 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.044 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 97.5% -0.22 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.044 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics |
|---|---|
| Description | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 348 | 232 | 221 |
| Least Squares Mean (Standard Error) [pills] |
-0.24
(0.029)
|
-0.27
(0.036)
|
-0.46
(0.037)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.519 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 97.5% -0.13 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.047 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 97.5% -0.32 to -0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.047 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics |
|---|---|
| Description | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 316 | 219 | 198 |
| Least Squares Mean (Standard Error) [pills] |
-0.28
(0.033)
|
-0.39
(0.041)
|
-0.57
(0.042)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.037 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 97.5% -0.23 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.053 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.29 | |
| Confidence Interval |
(2-Sided) 97.5% -0.41 to -0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.053 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics |
|---|---|
| Description | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 299 | 202 | 191 |
| Least Squares Mean (Standard Error) [pills] |
-0.29
(0.034)
|
-0.36
(0.041)
|
-0.60
(0.042)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.200 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 97.5% -0.19 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.053 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 97.5% -0.42 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.054 |
|
| Estimation Comments | ||
| Title | Response to Patient Global Impression of Change (PGIC) at Month 1 |
|---|---|
| Description | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. |
| Time Frame | Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 353 | 234 | 226 |
| Least Squares Mean (Standard Error) [units on a scale] |
3.50
(0.060)
|
2.97
(0.073)
|
2.76
(0.075)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.53 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.094 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.74 | |
| Confidence Interval |
(2-Sided) 95% -0.93 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.095 |
|
| Estimation Comments | ||
| Title | Response to PGIC at Month 2 |
|---|---|
| Description | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. |
| Time Frame | Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 353 | 231 | 225 |
| Least Squares Mean (Standard Error) [units on a scale] |
3.13
(0.062)
|
2.74
(0.076)
|
2.11
(0.077)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 95% -0.58 to -0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.098 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.02 | |
| Confidence Interval |
(2-Sided) 95% -1.21 to -0.82 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.099 |
|
| Estimation Comments | ||
| Title | Response to PGIC at Month 3 |
|---|---|
| Description | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. |
| Time Frame | Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 346 | 229 | 227 |
| Least Squares Mean (Standard Error) [units on a scale] |
3.14
(0.064)
|
2.53
(0.079)
|
2.01
(0.079)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.61 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to -0.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.101 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.12 | |
| Confidence Interval |
(2-Sided) 95% -1.32 to -0.92 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.102 |
|
| Estimation Comments | ||
| Title | Response to PGIC at Month 4 |
|---|---|
| Description | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. |
| Time Frame | Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 352 | 230 | 222 |
| Least Squares Mean (Standard Error) [units on a scale] |
3.16
(0.067)
|
2.54
(0.082)
|
1.91
(0.084)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to -0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.106 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.26 | |
| Confidence Interval |
(2-Sided) 95% -1.47 to -1.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.107 |
|
| Estimation Comments | ||
| Title | Response to PGIC at Month 5 |
|---|---|
| Description | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. |
| Time Frame | Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 350 | 233 | 223 |
| Least Squares Mean (Standard Error) [units on a scale] |
3.19
(0.070)
|
2.50
(0.086)
|
1.87
(0.088)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.69 | |
| Confidence Interval |
(2-Sided) 95% -0.91 to -0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.111 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.32 | |
| Confidence Interval |
(2-Sided) 95% -1.54 to -1.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.112 |
|
| Estimation Comments | ||
| Title | Response to PGIC at Month 6 |
|---|---|
| Description | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. |
| Time Frame | Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 308 | 207 | 200 |
| Least Squares Mean (Standard Error) [units on a scale] |
3.27
(0.077)
|
2.56
(0.094)
|
1.92
(0.096)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.72 | |
| Confidence Interval |
(2-Sided) 95% -0.96 to -0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.35 | |
| Confidence Interval |
(2-Sided) 95% -1.59 to -1.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.123 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in NRS Scores |
|---|---|
| Description | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 372 | 248 | 244 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.72
(0.069)
|
-1.00
(0.085)
|
-1.12
(0.085)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.52 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.109 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 97.5% -0.65 to -0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.110 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in NRS Scores |
|---|---|
| Description | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 348 | 232 | 221 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.91
(0.086)
|
-1.38
(0.106)
|
-1.87
(0.107)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.47 | |
| Confidence Interval |
(2-Sided) 97.5% -0.77 to -0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.137 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | -0.96 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.96 | |
| Confidence Interval |
(2-Sided) 97.5% -1.27 to -0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.138 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in NRS Scores |
|---|---|
| Description | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 316 | 219 | 198 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.15
(0.103)
|
-1.95
(0.126)
|
-2.76
(0.129)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.80 | |
| Confidence Interval |
(2-Sided) 97.5% -1.17 to -0.44 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.163 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.61 | |
| Confidence Interval |
(2-Sided) 97.5% -1.98 to -1.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.165 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in NRS Scores |
|---|---|
| Description | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 299 | 202 | 191 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.24
(0.106)
|
-1.92
(0.129)
|
-2.85
(0.132)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 97.5% -1.05 to -0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.167 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.61 | |
| Confidence Interval |
(2-Sided) 97.5% -1.99 to -1.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.170 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in NRS Scores |
|---|---|
| Description | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 288 | 198 | 182 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.15
(0.112)
|
-1.80
(0.136)
|
-2.75
(0.140)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 97.5% -1.04 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.176 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.60 | |
| Confidence Interval |
(2-Sided) 97.5% -2.00 to -1.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.179 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) |
|---|---|
| Description | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 345 | 233 | 217 |
| Least Squares Mean (Standard Error) [units on a scale] |
-14.47
(0.997)
|
-20.76
(1.213)
|
-24.23
(1.257)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -6.29 | |
| Confidence Interval |
(2-Sided) 95% -9.37 to -3.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.57 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -9.76 | |
| Confidence Interval |
(2-Sided) 95% -12.91 to -6.61 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.60 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in the Pain Domain of the EHP-30 |
|---|---|
| Description | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 312 | 217 | 197 |
| Least Squares Mean (Standard Error) [units on a scale] |
-17.71
(1.101)
|
-26.99
(1.321)
|
-36.46
(1.386)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -9.28 | |
| Confidence Interval |
(2-Sided) 95% -12.66 to -5.91 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.72 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -18.75 | |
| Confidence Interval |
(2-Sided) 95% -22.22 to -15.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.77 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in the Pain Domain of the EHP-30 |
|---|---|
| Description | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 249 | 177 | 162 |
| Least Squares Mean (Standard Error) [units on a scale] |
-15.42
(1.283)
|
-27.99
(1.522)
|
-40.52
(1.591)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -12.57 | |
| Confidence Interval |
(2-Sided) 95% -16.48 to -8.66 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.99 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -25.10 | |
| Confidence Interval |
(2-Sided) 95% -29.12 to -21.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.04 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 |
|---|---|
| Description | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 248 | 172 | 146 |
| Least Squares Mean (Standard Error) [units on a scale] |
-10.47
(1.239)
|
-11.26
(1.488)
|
-15.52
(1.614)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.685 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.78 | |
| Confidence Interval |
(2-Sided) 95% -4.59 to 3.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.94 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -5.04 | |
| Confidence Interval |
(2-Sided) 95% -9.04 to -1.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.03 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 |
|---|---|
| Description | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 228 | 167 | 133 |
| Least Squares Mean (Standard Error) [units on a scale] |
-12.57
(1.551)
|
-17.32
(1.813)
|
-26.44
(2.032)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.047 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -4.74 | |
| Confidence Interval |
(2-Sided) 95% -9.43 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.39 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -13.86 | |
| Confidence Interval |
(2-Sided) 95% -18.89 to -8.84 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.56 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 |
|---|---|
| Description | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 170 | 128 | 110 |
| Least Squares Mean (Standard Error) [units on a scale] |
-11.56
(1.909)
|
-16.27
(2.203)
|
-29.07
(2.384)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.107 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -4.71 | |
| Confidence Interval |
(2-Sided) 95% -10.43 to 1.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.91 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -17.51 | |
| Confidence Interval |
(2-Sided) 95% -23.52 to -11.50 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.06 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 251 | 171 | 162 |
| Least Squares Mean (Standard Error) [hours] |
-1.32
(0.236)
|
-1.20
(0.286)
|
-2.49
(0.294)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.741 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.61 to 0.85 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.37 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.16 | |
| Confidence Interval |
(2-Sided) 95% -1.90 to -0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 232 | 160 | 147 |
| Least Squares Mean (Standard Error) [hours] |
-1.29
(0.222)
|
-1.77
(0.266)
|
-2.56
(0.278)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.172 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.47 | |
| Confidence Interval |
(2-Sided) 95% -1.16 to 0.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.35 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.27 | |
| Confidence Interval |
(2-Sided) 95% -1.97 to -0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 215 | 148 | 140 |
| Least Squares Mean (Standard Error) [hours] |
-0.87
(0.277)
|
-1.92
(0.333)
|
-2.65
(0.343)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.05 | |
| Confidence Interval |
(2-Sided) 95% -1.90 to -0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.43 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.78 | |
| Confidence Interval |
(2-Sided) 95% -2.65 to -0.91 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.44 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 205 | 148 | 134 |
| Least Squares Mean (Standard Error) [hours] |
-1.08
(0.284)
|
-1.85
(0.334)
|
-2.44
(0.351)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.080 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.77 | |
| Confidence Interval |
(2-Sided) 95% -1.63 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.44 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.37 | |
| Confidence Interval |
(2-Sided) 95% -2.25 to -0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.45 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 209 | 147 | 128 |
| Least Squares Mean (Standard Error) [hours] |
-1.10
(0.258)
|
-1.75
(0.308)
|
-2.94
(0.330)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.106 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 95% -1.44 to 0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.40 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.85 | |
| Confidence Interval |
(2-Sided) 95% -2.67 to -1.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.42 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 159 | 120 | 105 |
| Least Squares Mean (Standard Error) [hours] |
-0.27
(0.409)
|
-1.02
(0.471)
|
-2.48
(0.503)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.232 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.75 | |
| Confidence Interval |
(2-Sided) 95% -1.97 to 0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.62 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.21 | |
| Confidence Interval |
(2-Sided) 95% -3.48 to -0.93 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.65 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 319 | 200 | 202 |
| Least Squares Mean (Standard Error) [hours] |
-1.27
(0.229)
|
-2.19
(0.289)
|
-2.89
(0.288)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.92 | |
| Confidence Interval |
(2-Sided) 95% -1.65 to -0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.37 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.62 | |
| Confidence Interval |
(2-Sided) 95% -2.35 to -0.90 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.37 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 287 | 192 | 183 |
| Least Squares Mean (Standard Error) [hours] |
-1.43
(0.295)
|
-2.75
(0.360)
|
-3.06
(0.369)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.33 | |
| Confidence Interval |
(2-Sided) 95% -2.24 to -0.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.47 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.64 | |
| Confidence Interval |
(2-Sided) 95% -2.56 to -0.71 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.47 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 278 | 185 | 179 |
| Least Squares Mean (Standard Error) [hours] |
-1.37
(0.292)
|
-3.00
(0.358)
|
-3.47
(0.363)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.63 | |
| Confidence Interval |
(2-Sided) 95% -2.53 to -0.72 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.46 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.10 | |
| Confidence Interval |
(2-Sided) 95% -3.02 to -1.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.47 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 264 | 170 | 171 |
| Least Squares Mean (Standard Error) [hours] |
-1.38
(0.265)
|
-2.59
(0.331)
|
-3.61
(0.330)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.21 | |
| Confidence Interval |
(2-Sided) 95% -2.05 to -0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.42 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.23 | |
| Confidence Interval |
(2-Sided) 95% -3.06 to -1.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.42 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 253 | 173 | 171 |
| Least Squares Mean (Standard Error) [hours] |
-2.13
(0.250)
|
-3.10
(0.302)
|
-3.94
(0.304)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.74 to -0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.81 | |
| Confidence Interval |
(2-Sided) 95% -2.58 to -1.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 191 | 145 | 139 |
| Least Squares Mean (Standard Error) [hours] |
-1.45
(0.313)
|
-2.73
(0.359)
|
-3.94
(0.367)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.28 | |
| Confidence Interval |
(2-Sided) 95% -2.22 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.48 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.49 | |
| Confidence Interval |
(2-Sided) 95% -3.44 to -1.54 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.48 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 246 | 170 | 157 |
| Least Squares Mean (Standard Error) [hours] |
-4.07
(0.555)
|
-4.93
(0.668)
|
-6.00
(0.694)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.326 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.86 | |
| Confidence Interval |
(2-Sided) 95% -2.57 to 0.85 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.87 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.93 | |
| Confidence Interval |
(2-Sided) 95% -3.67 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.89 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 228 | 158 | 145 |
| Least Squares Mean (Standard Error) [hours] |
-5.42
(0.560)
|
-6.83
(0.671)
|
-8.94
(0.701)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.107 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.41 | |
| Confidence Interval |
(2-Sided) 95% -3.13 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.88 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.52 | |
| Confidence Interval |
(2-Sided) 95% -5.28 to -1.75 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.90 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 213 | 147 | 136 |
| Least Squares Mean (Standard Error) [hours] |
-6.23
(0.526)
|
-7.24
(0.632)
|
-9.16
(0.657)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.219 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.01 | |
| Confidence Interval |
(2-Sided) 95% -2.63 to 0.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.82 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.93 | |
| Confidence Interval |
(2-Sided) 95% -4.59 to -1.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.84 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 201 | 146 | 132 |
| Least Squares Mean (Standard Error) [hours] |
-6.81
(0.465)
|
-8.41
(0.546)
|
-10.70
(0.573)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.60 | |
| Confidence Interval |
(2-Sided) 95% -3.01 to -0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.72 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.89 | |
| Confidence Interval |
(2-Sided) 95% -5.34 to -2.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.74 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 206 | 147 | 123 |
| Least Squares Mean (Standard Error) [hours] |
-7.80
(0.488)
|
-8.31
(0.577)
|
-10.93
(0.631)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.502 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.51 | |
| Confidence Interval |
(2-Sided) 95% -2.00 to 0.98 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.76 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.13 | |
| Confidence Interval |
(2-Sided) 95% -4.70 to -1.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.80 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 157 | 118 | 104 |
| Least Squares Mean (Standard Error) [hours] |
-6.75
(0.554)
|
-8.11
(0.637)
|
-11.21
(0.679)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.108 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.36 | |
| Confidence Interval |
(2-Sided) 95% -3.02 to 0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.85 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -4.47 | |
| Confidence Interval |
(2-Sided) 95% -6.19 to -2.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.88 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 314 | 200 | 199 |
| Least Squares Mean (Standard Error) [hours] |
-0.46
(0.224)
|
-1.64
(0.281)
|
-1.51
(0.282)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.19 | |
| Confidence Interval |
(2-Sided) 95% -1.90 to -0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.05 | |
| Confidence Interval |
(2-Sided) 95% -1.76 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 285 | 190 | 181 |
| Least Squares Mean (Standard Error) [hours] |
-1.17
(0.238)
|
-1.93
(0.291)
|
-2.23
(0.299)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | mixed-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.76 | |
| Confidence Interval |
(2-Sided) 95% -1.49 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.06 | |
| Confidence Interval |
(2-Sided) 95% -1.81 to -0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 275 | 185 | 178 |
| Least Squares Mean (Standard Error) [hours] |
-1.35
(0.210)
|
-1.89
(0.256)
|
-2.33
(0.261)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.103 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.54 | |
| Confidence Interval |
(2-Sided) 95% -1.19 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.33 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.98 | |
| Confidence Interval |
(2-Sided) 95% -1.64 to -0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 263 | 168 | 170 |
| Least Squares Mean (Standard Error) [hours] |
-1.51
(0.224)
|
-1.81
(0.280)
|
-2.55
(0.278)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.390 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -1.01 to 0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.05 | |
| Confidence Interval |
(2-Sided) 95% -1.75 to -0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 253 | 172 | 169 |
| Least Squares Mean (Standard Error) [hours] |
-1.67
(0.169)
|
-1.86
(0.205)
|
-2.71
(0.206)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.460 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to 0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.04 | |
| Confidence Interval |
(2-Sided) 95% -1.57 to -0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 191 | 145 | 135 |
| Least Squares Mean (Standard Error) [hours] |
-1.48
(0.232)
|
-2.07
(0.265)
|
-2.78
(0.275)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.095 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.59 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.35 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.30 | |
| Confidence Interval |
(2-Sided) 95% -2.01 to -0.59 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 251 | 171 | 162 |
| Least Squares Mean (Standard Error) [hours] |
-5.46
(0.615)
|
-6.17
(0.745)
|
-8.69
(0.764)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.462 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -0.71 | |
| Confidence Interval |
(2-Sided) 95% -2.61 to 1.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.97 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.23 | |
| Confidence Interval |
(2-Sided) 95% -5.16 to -1.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.98 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 232 | 160 | 147 |
| Least Squares Mean (Standard Error) [hours] |
-6.70
(0.621)
|
-8.72
(0.746)
|
-11.56
(0.778)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.02 | |
| Confidence Interval |
(2-Sided) 95% -3.93 to -0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.97 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -4.86 | |
| Confidence Interval |
(2-Sided) 95% -6.82 to -2.90 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 215 | 148 | 140 |
| Least Squares Mean (Standard Error) [hours] |
-7.00
(0.654)
|
-9.20
(0.787)
|
-11.90
(0.808)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.20 | |
| Confidence Interval |
(2-Sided) 95% -4.21 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.03 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -4.91 | |
| Confidence Interval |
(2-Sided) 95% -6.95 to -2.86 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.04 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 205 | 148 | 134 |
| Least Squares Mean (Standard Error) [hours] |
-7.84
(0.605)
|
-10.26
(0.712)
|
-13.09
(0.747)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.42 | |
| Confidence Interval |
(2-Sided) 95% -4.26 to -0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.94 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -5.25 | |
| Confidence Interval |
(2-Sided) 95% -7.14 to -3.36 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.96 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 209 | 147 | 128 |
| Least Squares Mean (Standard Error) [hours] |
-8.87
(0.604)
|
-10.04
(0.719)
|
-14.00
(0.771)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.215 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.17 | |
| Confidence Interval |
(2-Sided) 95% -3.02 to 0.68 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.94 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -5.13 | |
| Confidence Interval |
(2-Sided) 95% -7.06 to -3.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.98 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 159 | 120 | 105 |
| Least Squares Mean (Standard Error) [hours] |
-6.88
(0.761)
|
-9.14
(0.874)
|
-13.67
(0.936)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.053 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.25 | |
| Confidence Interval |
(2-Sided) 95% -4.53 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -6.79 | |
| Confidence Interval |
(2-Sided) 95% -9.17 to -4.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.21 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 1 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 319 | 200 | 202 |
| Least Squares Mean (Standard Error) [hours] |
-1.76
(0.352)
|
-3.88
(0.445)
|
-4.36
(0.443)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.12 | |
| Confidence Interval |
(2-Sided) 95% -3.24 to -1.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.57 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.60 | |
| Confidence Interval |
(2-Sided) 95% -3.71 to -1.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.57 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 2 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 287 | 192 | 183 |
| Least Squares Mean (Standard Error) [hours] |
-2.60
(0.423)
|
-4.69
(0.517)
|
-5.25
(0.529)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.09 | |
| Confidence Interval |
(2-Sided) 95% -3.40 to -0.78 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.67 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.65 | |
| Confidence Interval |
(2-Sided) 95% -3.98 to -1.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.68 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 3 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 278 | 185 | 179 |
| Least Squares Mean (Standard Error) [hours] |
-2.73
(0.394)
|
-4.90
(0.483)
|
-5.73
(0.492)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.17 | |
| Confidence Interval |
(2-Sided) 95% -3.39 to -0.95 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.62 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.00 | |
| Confidence Interval |
(2-Sided) 95% -4.23 to -1.76 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.63 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 4 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 264 | 170 | 171 |
| Least Squares Mean (Standard Error) [hours] |
-2.89
(0.403)
|
-4.43
(0.502)
|
-6.13
(0.501)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.54 | |
| Confidence Interval |
(2-Sided) 95% -2.80 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.64 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.24 | |
| Confidence Interval |
(2-Sided) 95% -4.50 to -1.98 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.64 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 5 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 253 | 173 | 171 |
| Least Squares Mean (Standard Error) [hours] |
-3.80
(0.349)
|
-4.94
(0.423)
|
-6.62
(0.425)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.14 | |
| Confidence Interval |
(2-Sided) 95% -2.22 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.55 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -2.83 | |
| Confidence Interval |
(2-Sided) 95% -3.91 to -1.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.55 |
|
| Estimation Comments | ||
| Title | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
|---|---|
| Description | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. |
| Time Frame | Baseline, Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 191 | 145 | 139 |
| Least Squares Mean (Standard Error) [hours] |
-2.94
(0.433)
|
-4.78
(0.496)
|
-6.69
(0.507)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 150 mg QD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -1.83 | |
| Confidence Interval |
(2-Sided) 95% -3.13 to -0.54 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.66 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix 200 mg BID |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means |
| Estimated Value | -3.75 | |
| Confidence Interval |
(2-Sided) 95% -5.06 to -2.44 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.67 |
|
| Estimation Comments | ||
| Title | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period |
|---|---|
| Description | |
| Time Frame | Up to Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 374 | 249 | 248 |
| Baseline |
69
18.4%
|
54
21.7%
|
51
20.6%
|
| Month 1 |
70
18.7%
|
50
20.1%
|
47
19%
|
| Month 2 |
59
15.8%
|
38
15.3%
|
33
13.3%
|
| Month 3 |
66
17.6%
|
37
14.9%
|
48
19.4%
|
| Month 4 |
54
14.4%
|
35
14.1%
|
42
16.9%
|
| Month 5 |
43
11.5%
|
32
12.9%
|
22
8.9%
|
| Month 6 |
38
10.2%
|
26
10.4%
|
21
8.5%
|
| Overall |
189
50.5%
|
126
50.6%
|
113
45.6%
|
| Title | Number of Days of Hospitalization |
|---|---|
| Description | |
| Time Frame | Up to Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 15 | 3 | 13 |
| Mean (Standard Deviation) [days] |
2.9
(2.45)
|
2.0
(1.00)
|
2.0
(1.68)
|
| Title | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type |
|---|---|
| Description | |
| Time Frame | Up to Month 6 of Treatment Period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. |
| Arm/Group Title | Placebo | Elagolix 150 mg QD | Elagolix 200 mg BID |
|---|---|---|---|
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period |
| Measure Participants | 374 | 249 | 248 |
| All Categories |
62
16.6%
|
21
8.4%
|
32
12.9%
|
| Abdominal Hysterectomy |
0
0%
|
0
0%
|
0
0%
|
| Angiography |
0
0%
|
0
0%
|
0
0%
|
| Arthroscopy |
0
0%
|
0
0%
|
1
0.4%
|
| Biopsy |
1
0.3%
|
0
0%
|
1
0.4%
|
| Blood Draw |
27
7.2%
|
7
2.8%
|
16
6.5%
|
| Consultation |
6
1.6%
|
3
1.2%
|
3
1.2%
|
| CT Scan |
21
5.6%
|
3
1.2%
|
6
2.4%
|
| Diagnostic Laparoscopy |
0
0%
|
1
0.4%
|
0
0%
|
| Electrocardiogram |
3
0.8%
|
1
0.4%
|
3
1.2%
|
| Endometrial Ablation |
0
0%
|
0
0%
|
0
0%
|
| Histological Exam |
0
0%
|
0
0%
|
0
0%
|
| Intrauterine Insemination |
0
0%
|
0
0%
|
0
0%
|
| In Vitro Fertilization |
0
0%
|
0
0%
|
0
0%
|
| Laparoscopic Hysterectomy |
0
0%
|
0
0%
|
0
0%
|
| Laparotomy |
0
0%
|
0
0%
|
0
0%
|
| Magnetic Resonance Imaging |
0
0%
|
0
0%
|
0
0%
|
| Oophorectomy |
0
0%
|
0
0%
|
0
0%
|
| Pelvic Exam |
5
1.3%
|
1
0.4%
|
2
0.8%
|
| Physical Examination |
32
8.6%
|
10
4%
|
15
6%
|
| Surgery for Adhesions |
0
0%
|
0
0%
|
0
0%
|
| Therapeutic Laparoscopy |
0
0%
|
0
0%
|
1
0.4%
|
| Transfusion |
0
0%
|
0
0%
|
0
0%
|
| Ultrasound |
14
3.7%
|
3
1.2%
|
6
2.4%
|
| Urine Test |
26
7%
|
8
3.2%
|
11
4.4%
|
| Vaginal Hysterectomy |
0
0%
|
0
0%
|
0
0%
|
| X-Ray |
14
3.7%
|
2
0.8%
|
5
2%
|
| Other (Not Specified) |
16
4.3%
|
10
4%
|
10
4%
|
Adverse Events
| Time Frame | From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events (AEs) are defined as treatment-emergent if they began on or after the date of the first dose of study drug through up to 30 days after the last dose of study drug for participants who did not enroll in the separate extension study (Study M12-667, NCT01760954). For participants who enrolled in the separate extension study, treatment-emergent AEs are those that began on or after the first dose of study drug until the day prior to the first dose date in the extension study. | |||||
| Arm/Group Title | Placebo | Elagolix 150 MG QD | Elagolix 200 MG BID | |||
| Arm/Group Description | Placebo BID for the 6-month Treatment Period | Elagolix 150 mg QD for the 6-month Treatment Period | Elagolix 200 mg BID for the 6-month Treatment Period | |||
All Cause Mortality |
||||||
| Placebo | Elagolix 150 MG QD | Elagolix 200 MG BID | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Placebo | Elagolix 150 MG QD | Elagolix 200 MG BID | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/374 (3.2%) | 2/249 (0.8%) | 7/248 (2.8%) | |||
| Gastrointestinal disorders | ||||||
| CONSTIPATION | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| General disorders | ||||||
| CHEST PAIN | 1/374 (0.3%) | 1/249 (0.4%) | 0/248 (0%) | |||
| Infections and infestations | ||||||
| APPENDICITIS | 1/374 (0.3%) | 0/249 (0%) | 1/248 (0.4%) | |||
| CLOSTRIDIUM DIFFICILE COLITIS | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| MENINGITIS VIRAL | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| PYELONEPHRITIS | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| Injury, poisoning and procedural complications | ||||||
| UPPER LIMB FRACTURE | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| Investigations | ||||||
| BLOOD POTASSIUM DECREASED | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| RHEUMATOID ARTHRITIS | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| SYNOVITIS | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| Pregnancy, puerperium and perinatal conditions | ||||||
| ECTOPIC PREGNANCY | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| Psychiatric disorders | ||||||
| ANXIETY | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| Renal and urinary disorders | ||||||
| CALCULUS URETERIC | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| HYDRONEPHROSIS | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| NEPHROLITHIASIS | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| URETERIC STENOSIS | 0/374 (0%) | 1/249 (0.4%) | 0/248 (0%) | |||
| Reproductive system and breast disorders | ||||||
| ENDOMETRIOSIS | 1/374 (0.3%) | 0/249 (0%) | 2/248 (0.8%) | |||
| HAEMORRHAGIC OVARIAN CYST | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| OVARIAN CYST RUPTURED | 0/374 (0%) | 0/249 (0%) | 1/248 (0.4%) | |||
| PELVIC PAIN | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| DYSPNOEA | 0/374 (0%) | 1/249 (0.4%) | 0/248 (0%) | |||
| DYSPNOEA EXERTIONAL | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| Social circumstances | ||||||
| VICTIM OF SEXUAL ABUSE | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
| Vascular disorders | ||||||
| DEEP VEIN THROMBOSIS | 1/374 (0.3%) | 0/249 (0%) | 0/248 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | Elagolix 150 MG QD | Elagolix 200 MG BID | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 180/374 (48.1%) | 147/249 (59%) | 159/248 (64.1%) | |||
| Gastrointestinal disorders | ||||||
| NAUSEA | 51/374 (13.6%) | 25/249 (10%) | 40/248 (16.1%) | |||
| VOMITING | 19/374 (5.1%) | 11/249 (4.4%) | 10/248 (4%) | |||
| General disorders | ||||||
| FATIGUE | 23/374 (6.1%) | 14/249 (5.6%) | 16/248 (6.5%) | |||
| Infections and infestations | ||||||
| NASOPHARYNGITIS | 7/374 (1.9%) | 13/249 (5.2%) | 11/248 (4.4%) | |||
| SINUSITIS | 17/374 (4.5%) | 14/249 (5.6%) | 12/248 (4.8%) | |||
| UPPER RESPIRATORY TRACT INFECTION | 24/374 (6.4%) | 19/249 (7.6%) | 8/248 (3.2%) | |||
| URINARY TRACT INFECTION | 36/374 (9.6%) | 19/249 (7.6%) | 16/248 (6.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| BACK PAIN | 26/374 (7%) | 10/249 (4%) | 10/248 (4%) | |||
| Nervous system disorders | ||||||
| HEADACHE | 37/374 (9.9%) | 38/249 (15.3%) | 43/248 (17.3%) | |||
| Psychiatric disorders | ||||||
| ANXIETY | 15/374 (4%) | 6/249 (2.4%) | 15/248 (6%) | |||
| DEPRESSION | 10/374 (2.7%) | 9/249 (3.6%) | 13/248 (5.2%) | |||
| INSOMNIA | 9/374 (2.4%) | 16/249 (6.4%) | 18/248 (7.3%) | |||
| Reproductive system and breast disorders | ||||||
| AMENORRHOEA | 1/374 (0.3%) | 8/249 (3.2%) | 14/248 (5.6%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| ACNE | 16/374 (4.3%) | 13/249 (5.2%) | 10/248 (4%) | |||
| NIGHT SWEATS | 5/374 (1.3%) | 6/249 (2.4%) | 14/248 (5.6%) | |||
| Vascular disorders | ||||||
| HOT FLUSH | 26/374 (7%) | 59/249 (23.7%) | 105/248 (42.3%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie (prior sponsor Abbott) |
| Phone | 800-633-9110 |
Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01620528
Other Study ID Numbers:
- M12-665
First Posted:
Jun 15, 2012
Last Update Posted:
Sep 18, 2018
Last Verified:
Mar 1, 2017