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 | Plac |
|---|