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ELARIS EM-II: A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01931670
Collaborator
(none)
815
Enrollment
3
Arms
39.3
Actual Duration (Months)

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 subjects.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Study Design

Study Type:
Interventional
Actual Enrollment :
815 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
Actual Study Start Date :
Sep 9, 2013
Actual Primary Completion Date :
Jan 6, 2016
Actual Study Completion Date :
Dec 19, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo twice daily (BID) for the 6-month Treatment Period

Other: placebo
Experimental: Elagolix 150 mg QD

Elagolix 150 mg once daily (QD) for the 6-month Treatment Period

Drug: Elagolix
Other Names:
  • ABT-620
  • elagolix sodium

    		•
    Experimental: Elagolix 200 mg BID

    Elagolix 200 mg BID for the 6-month Treatment Period

    Drug: Elagolix
    Other Names:
  • ABT-620
  • elagolix sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.

    2. 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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.

    Secondary Outcome Measures

    1. 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).

    2. 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).

    3. 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).

    4. 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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.

    5. 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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.

    6. 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).

    7. Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) [Baseline, Month 3 of Treatment Period]

      Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.

    8. Percentage of Responders for Each Month, Except Month 3, in DYS [Months 1, 2, 4, 5, 6 of the Treatment Period]

      The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.

    9. Percentage of Responders for Each Month, Except Month 3, in NMPP [Months 1, 2, 4, 5, 6 of the Treatment Period]

      The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.

    10. Percentage of Responders at Each Month for DYSP [Months 1, 2, 3, 4, 5, 6 of Treatment Period]

      The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.

    11. Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS [Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period]

      The DYS pain scale ranges from 0 (none) to 3 (severe).

    12. Percent Change From Baseline to Each Month in Mean Pain Score for DYS [Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period]

      The DYS pain scale ranges from 0 (none) to 3 (severe).

    13. Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP [Baseline, Months 1, 2, 3, 4, 5 of Treatment Period]

      The NMPP pain scale ranges from 0 (none) to 3 (severe).

    14. Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP [Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period]

      The NMPP pain scale ranges from 0 (none) to 3 (severe).

    15. Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP [Baseline, Months 1, 2, 4, 5, 6 of Treatment Period]

      The DYSP pain scale ranged from 0 (absent) to 3 (severe).

    16. Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics [Baseline, Months 1, 2, 4, 5]

      Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.

    17. Patient Global Impression of Change (PGIC) Questionnaire [Months 1, 2, 3, 4, 5, 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.

    18. Change From Baseline to Each Month, Except Month 3, in NRS Scores [Baseline, Months 1, 2, 4, 5, 6 of Treatment Period]

      The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

    19. Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores [Baseline, Months 1, 3, 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 domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

    20. Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores [Baseline, Months 1, 3, 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 domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

    21. Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism [Baseline, Months 1, 2, 3, 4, 5, 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.

    22. Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism [Baseline, Months 1, 2, 3, 4, 5, 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.

    23. Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism [Baseline, Months 1, 2, 3, 4, 5, 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.

    24. Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism [Baseline, Months 1, 2, 3, 4, 5, 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.

    25. Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace [Baseline, Months 1, 2, 3, 4, 5, 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.

    26. Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household [Baseline, Months 1, 2, 3, 4, 5, 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.

    27. Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period [Months 1, 2, 3, 4, 5, 6 of Treatment Period]

      This is assessed using Health Resource Utilization Questionnaire (HRUQ).

    28. Number of Days of Hospitalization [Up to Month 6 of Treatment Period]

      This is assessed using HRUQ.

    29. Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type [Up to Month 6 of Treatment Period]

      This is assessed using HRUQ.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.

    2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.

    3. Agrees to use required birth control methods during the entire length of participation in the study.

    4. Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater 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 regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.

    Exclusion Criteria:

    1. 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.

    2. 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.

    3. 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.

    4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.

    5. Subject has a history of osteoporosis or other metabolic bone disease.

    6. Subject has a current history of undiagnosed abnormal uterine bleeding.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01931670
    Other Study ID Numbers:
    • M12-671
    • 2011-004295-11
    First Posted:
    Aug 29, 2013
    Last Update Posted:
    Sep 7, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Non-Menstrual Pelvic Pain (NMPP)
    Dysmenorrhea (DYS)
    Elagolix
    Endometriosis Associated Pain
    Gonadotropin-Releasing Hormone Antagonist
    Additional relevant MeSH terms:
    Endometriosis

    Study Results

    Participant Flow

    Recruitment Details Participants were randomized at 187 sites in Argentina, Austria, Australia, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, the United States, and the United Kingdom.
    Pre-assignment Detail The study consisted of 4 periods: a Washout Period (if applicable); a Screening Period of ≤ 100 days prior to first dose; a 6-month Treatment Period; and a Post-Treatment Follow-up Period of ≤ 12 months (if applicable). Participants were randomized into the study in a 3:2:2 ratio to placebo, elagolix 150 mg QD, or elagolix 200 mg BID, respectively.
    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 360 226 229
    COMPLETED 270 178 184
    NOT COMPLETED 90 48 45
    Period Title: Treatment Period
    STARTED 61 40 54
    Completed PTFU Month 6 42 24 18
    Completed PTFU Month 12 0 4 15
    COMPLETED 42 28 33
    NOT COMPLETED 19 12 21

    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 360 226 229 815
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.1
    (6.69)
    33.1
    (6.80)
    33.4
    (6.67)
    33.2
    (6.71)
    Sex: Female, Male (Count of Participants)
    Female
    360
    100%
    226
    100%
    229
    100%
    815
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
    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 353 221 225
    Number [percentage of participants]
    22.7
    6.3%
    43.4
    19.2%
    72.4
    31.6%
    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 An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
    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 An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
    Method Regression, Logistic
    Comments
    2. Primary Outcome
    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) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
    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 353 221 225
    Number [percentage of participants]
    36.5
    10.1%
    49.8
    22%
    57.8
    25.2%
    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 0.003
    Comments An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
    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 An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
    Method Regression, Logistic
    Comments
    3. Secondary Outcome
    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 312 204 209
    Least Squares Mean (Standard Error) [units on a scale]
    -1.33
    (0.097)
    -1.90
    (0.122)
    -2.55
    (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 For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.57
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.156
    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 For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -1.22
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.156
    Estimation Comments
    4. Secondary Outcome
    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 273 185 187
    Least Squares Mean (Standard Error) [units on a scale]
    -0.52
    (0.047)
    -1.06
    (0.057)
    -1.65
    (0.057)
    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 For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.54
    Confidence Interval (2-Sided) %
    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 For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -1.13
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.074
    Estimation Comments
    5. Secondary Outcome
    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 273 185 187
    Least Squares Mean (Standard Error) [units on a scale]
    -0.48
    (0.035)
    -0.63
    (0.044)
    -0.80
    (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 0.009
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.15
    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 For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.32
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.056
    Estimation Comments
    6. Secondary Outcome
    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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 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 312 204 209
    Least Squares Mean (Standard Error) [number of pills]
    -0.31
    (0.028)
    -0.36
    (0.035)
    -0.49
    (0.034)
    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 0.26
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.05
    Confidence Interval (2-Sided) %
    to
    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 Ranked secondary efficacy endpoint 4 of 7.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.18
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.044
    Estimation Comments
    7. Secondary Outcome
    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 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 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 273 185 187
    Least Squares Mean (Standard Error) [number of pills]
    -0.32
    (0.030)
    -0.40
    (0.038)
    -0.52
    (0.037)
    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 0.088
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.08
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.048
    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 For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.21
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.048
    Estimation Comments
    8. Secondary Outcome
    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 226 145 150
    Least Squares Mean (Standard Error) [units on a scale]
    -0.30
    (0.042)
    -0.39
    (0.052)
    -0.60
    (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 0.172
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    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: 0.067
    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 < 0.001
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.30
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.067
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
    Description Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 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 312 204 209
    Least Squares Mean (Standard Error) [number of pills]
    -0.12
    (0.019)
    -0.12
    (0.024)
    -0.21
    (0.023)
    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 0.968
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value 0.00
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.030
    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 0.007
    Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter Difference in LS Mean Change
    Estimated Value -0.08
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.030
    Estimation Comments
    10. Secondary Outcome
    Title Percentage of Responders for Each Month, Except Month 3, in DYS
    Description The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
    Time Frame Months 1, 2, 4, 5, 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. Participants with an assessment at given time point.
    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 358 221 225
    Month 1
    17.3
    4.8%
    33.0
    14.6%
    46.2
    20.2%
    Month 2
    19.0
    5.3%
    39.4
    17.4%
    69.8
    30.5%
    Month 4
    21.2
    5.9%
    45.9
    20.3%
    79.8
    34.8%
    Month 5
    23.7
    6.6%
    44.1
    19.5%
    80.7
    35.2%
    Month 6
    25.4
    7.1%
    46.2
    20.4%
    76.9
    33.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.361
    Confidence Interval (2-Sided) 97.5%
    1.507 to 3.697
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.185
    Confidence Interval (2-Sided) 97.5%
    2.707 to 6.469
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.795
    Confidence Interval (2-Sided) 97.5%
    1.811 to 4.312
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.378
    Confidence Interval (2-Sided) 97.5%
    6.615 to 16.282
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.178
    Confidence Interval (2-Sided) 97.5%
    2.084 to 4.845
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 15.216
    Confidence Interval (2-Sided) 97.5%
    9.429 to 24.554
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.548
    Confidence Interval (2-Sided) 97.5%
    1.683 to 3.859
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 14.055
    Confidence Interval (2-Sided) 97.5%
    8.716 to 22.664
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.536
    Confidence Interval (2-Sided) 97.5%
    1.685 to 3.816
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.106
    Confidence Interval (2-Sided) 97.5%
    6.434 to 15.874
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Percentage of Responders for Each Month, Except Month 3, in NMPP
    Description The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
    Time Frame Months 1, 2, 4, 5, 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. Participants with an assessment at given time point.
    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 358 221 225
    Month 1
    23.5
    6.5%
    27.6
    12.2%
    29.3
    12.8%
    Month 2
    32.1
    8.9%
    39.8
    17.6%
    50.7
    22.1%
    Month 4
    38.7
    10.8%
    51.4
    22.7%
    63.2
    27.6%
    Month 5
    39.8
    11.1%
    50.5
    22.3%
    63.2
    27.6%
    Month 6
    40.6
    11.3%
    51.6
    22.8%
    62.2
    27.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.376
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.191
    Confidence Interval (2-Sided) 97.5%
    0.765 to 1.855
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.101
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.376
    Confidence Interval (2-Sided) 97.5%
    0.890 to 2.127
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.088
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.358
    Confidence Interval (2-Sided) 97.5%
    0.909 to 2.029
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.208
    Confidence Interval (2-Sided) 97.5%
    1.488 to 3.278
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.678
    Confidence Interval (2-Sided) 97.5%
    1.136 to 2.477
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.722
    Confidence Interval (2-Sided) 97.5%
    1.832 to 4.044
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.537
    Confidence Interval (2-Sided) 97.5%
    1.042 to 2.267
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.598
    Confidence Interval (2-Sided) 97.5%
    1.750 to 3.857
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.565
    Confidence Interval (2-Sided) 97.5%
    1.062 to 2.306
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.412
    Confidence Interval (2-Sided) 97.5%
    1.630 to 3.570
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Percentage of Responders at Each Month for DYSP
    Description The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
    Time Frame Months 1, 2, 3, 4, 5, 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. Participants with an assessment at given time point.
    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 262 168 171
    Month 1
    33.3
    9.3%
    33.8
    15%
    35.1
    15.3%
    Month 2
    33.2
    9.2%
    39.9
    17.7%
    47.4
    20.7%
    Month 3
    39.5
    11%
    44.0
    19.5%
    53.7
    23.4%
    Month 4
    38.5
    10.7%
    41.3
    18.3%
    59.8
    26.1%
    Month 5
    37.4
    10.4%
    42.8
    18.9%
    58.1
    25.4%
    Month 6
    39.4
    10.9%
    39.9
    17.7%
    55.8
    24.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.901
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.028
    Confidence Interval (2-Sided) 97.5%
    0.624 to 1.693
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.65
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.103
    Confidence Interval (2-Sided) 97.5%
    0.680 to 1.789
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.154
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.351
    Confidence Interval (2-Sided) 97.5%
    0.841 to 2.170
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.871
    Confidence Interval (2-Sided) 97.5%
    1.175 to 2.979
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.294
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.250
    Confidence Interval (2-Sided) 97.5%
    0.776 to 2.013
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.865
    Confidence Interval (2-Sided) 97.5%
    1.163 to 2.989
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.521
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.145
    Confidence Interval (2-Sided) 97.5%
    0.713 to 1.839
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.474
    Confidence Interval (2-Sided) 97.5%
    1.544 to 3.963
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.27
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.262
    Confidence Interval (2-Sided) 97.5%
    0.787 to 2.023
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.416
    Confidence Interval (2-Sided) 97.5%
    1.500 to 3.891
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.953
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.013
    Confidence Interval (2-Sided) 97.5%
    0.631 to 1.624
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.997
    Confidence Interval (2-Sided) 97.5%
    1.253 to 3.183
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
    Description The DYS pain scale ranges from 0 (none) to 3 (severe).
    Time Frame Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 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 with an assessment at given time point.
    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 358 221 225
    Month 1
    -0.33
    (0.044)
    -0.86
    (0.056)
    -1.11
    (0.056)
    Month 2
    -0.39
    (0.042)
    -0.84
    (0.053)
    -1.67
    (0.053)
    Month 3
    -0.45
    (0.042)
    -0.97
    (0.053)
    -1.70
    (0.052)
    Month 4
    -0.47
    (0.044)
    -1.05
    (0.054)
    -1.74
    (0.054)
    Month 5
    -0.50
    (0.045)
    -0.99
    (0.055)
    -1.76
    (0.055)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    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 -0.53
    Confidence Interval (2-Sided) 97.5%
    -0.69 to -0.37
    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 Month 1
    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 -0.78
    Confidence Interval (2-Sided) 97.5%
    -0.94 to -0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.071
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    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 -0.44
    Confidence Interval (2-Sided) 97.5%
    -0.6 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.068
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -1.27
    Confidence Interval (2-Sided) 97.5%
    -1.43 to -1.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.068
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    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 -0.53
    Confidence Interval (2-Sided) 97.5%
    -0.68 to -0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.068
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -1.25
    Confidence Interval (2-Sided) 97.5%
    -1.4 to -1.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.067
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    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 -0.58
    Confidence Interval (2-Sided) 97.5%
    -0.73 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.07
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -1.27
    Confidence Interval (2-Sided) 97.5%
    -1.42 to -1.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.07
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    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 -0.49
    Confidence Interval (2-Sided) 97.5%
    -0.65 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.071
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -1.26
    Confidence Interval (2-Sided) 97.5%
    -1.42 to -1.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.071
    Estimation Comments
    14. Secondary Outcome
    Title Percent Change From Baseline to Each Month in Mean Pain Score for DYS
    Description The DYS pain scale ranges from 0 (none) to 3 (severe).
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 358 221 224
    Month 1
    -14.36
    (2.268)
    -39.67
    (2.886)
    -53.68
    (2.867)
    Month 2
    -17.36
    (2.087)
    -39.26
    (2.629)
    -80.68
    (2.638)
    Month 3
    -20.58
    (2.031)
    -45.73
    (2.528)
    -82.52
    (2.513)
    Month 4
    -21.55
    (2.104)
    -48.52
    (2.601)
    -83.92
    (2.599)
    Month 5
    -22.63
    (2.159)
    -45.99
    (2.664)
    -85.53
    (2.650)
    Month 6
    -23.81
    (2.225)
    -49.70
    (2.738)
    -80.43
    (2.727)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    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 -25.31
    Confidence Interval (2-Sided) 97.5%
    -33.55 to -17.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.669
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    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 -39.32
    Confidence Interval (2-Sided) 97.5%
    -47.53 to -31.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.657
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    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 -21.9
    Confidence Interval (2-Sided) 97.5%
    -29.44 to -14.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.355
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -63.31
    Confidence Interval (2-Sided) 97.5%
    -70.87 to -55.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.365
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    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 -25.15
    Confidence Interval (2-Sided) 97.5%
    -32.43 to -17.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.241
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -61.94
    Confidence Interval (2-Sided) 97.5%
    -69.20 to -54.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.233
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    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 -26.97
    Confidence Interval (2-Sided) 97.5%
    -34.48 to -19.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.344
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -62.37
    Confidence Interval (2-Sided) 97.5%
    -69.89 to -54.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.346
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    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 -23.36
    Confidence Interval (2-Sided) 97.5%
    -31.06 to -15.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.428
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -62.9
    Confidence Interval (2-Sided) 97.5%
    -70.58 to -55.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.42
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    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 -25.89
    Confidence Interval (2-Sided) 97.5%
    -33.81 to -17.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.528
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -56.62
    Confidence Interval (2-Sided) 97.5%
    -64.53 to -48.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.522
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
    Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
    Time Frame Baseline, Months 1, 2, 3, 4, 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 with an assessment at given time point.
    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 358 221 225
    Month 1
    -0.22
    (0.025)
    -0.24
    (0.031)
    -0.31
    (0.031)
    Month 2
    -0.34
    (0.027)
    -0.41
    (0.034)
    -0.54
    (0.034)
    Month 3
    -0.39
    (0.031)
    -0.50
    (0.039)
    -0.69
    (0.039)
    Month 4
    -0.45
    (0.033)
    -0.54
    (0.041)
    -0.78
    (0.041)
    Month 5
    -0.48
    (0.034)
    -0.58
    (0.042)
    -0.81
    (0.042)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.549
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.02
    Confidence Interval (2-Sided) 97.5%
    -0.11 to 0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.04
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.09
    Confidence Interval (2-Sided) 97.5%
    -0.18 to 0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.04
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    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%
    -0.17 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.044
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -0.20
    Confidence Interval (2-Sided) 97.5%
    -0.30 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.043
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.041
    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%
    -0.22 to 0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.05
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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: 0.05
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.081
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.09
    Confidence Interval (2-Sided) 97.5%
    -0.21 to 0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.052
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -0.33
    Confidence Interval (2-Sided) 97.5%
    -0.45 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.052
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.062
    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%
    -0.22 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.054
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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%
    -0.46 to -0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.054
    Estimation Comments
    16. Secondary Outcome
    Title Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
    Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 358 221 225
    Month 1
    -12.43
    (1.814)
    -15.47
    (2.313)
    -18.86
    (2.288)
    Month 2
    -21.13
    (1.836)
    -26.30
    (2.326)
    -34.32
    (2.316)
    Month 3
    -25.78
    (2.104)
    -32.63
    (2.643)
    -44.83
    (2.625)
    Month 4
    -29.94
    (2.170)
    -36.19
    (2.711)
    -51.52
    (2.696)
    Month 5
    -31.96
    (2.214)
    -38.17
    (2.756)
    -53.61
    (2.737)
    Month 6
    -31.25
    (2.349)
    -42.09
    (2.914)
    -52.42
    (2.897)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.301
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -3.04
    Confidence Interval (2-Sided) 97.5%
    -9.64 to 3.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.94
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.028
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -6.43
    Confidence Interval (2-Sided) 97.5%
    -12.99 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.92
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -5.17
    Confidence Interval (2-Sided) 97.5%
    -11.82 to 1.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.964
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -13.19
    Confidence Interval (2-Sided) 97.5%
    -19.83 to -6.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.956
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.043
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -6.84
    Confidence Interval (2-Sided) 97.5%
    -14.43 to 0.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.379
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -19.05
    Confidence Interval (2-Sided) 97.5%
    -26.61 to -11.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.364
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.072
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -6.25
    Confidence Interval (2-Sided) 97.5%
    -14.05 to 1.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.473
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -21.58
    Confidence Interval (2-Sided) 97.5%
    -29.35 to -13.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.46
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.08
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -6.21
    Confidence Interval (2-Sided) 97.5%
    -14.15 to 1.73
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.536
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -21.66
    Confidence Interval (2-Sided) 97.5%
    -29.56 to -13.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.52
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    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 -10.83
    Confidence Interval (2-Sided) 97.5%
    -19.24 to -2.43
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.744
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -21.16
    Confidence Interval (2-Sided) 97.5%
    -29.54 to -12.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.729
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
    Description The DYSP pain scale ranged from 0 (absent) to 3 (severe).
    Time Frame Baseline, Months 1, 2, 4, 5, 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. Participants with an assessment at given timepoint.
    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 261 161 171
    Month 1
    -0.21
    (0.037)
    -0.19
    (0.046)
    -0.26
    (0.045)
    Month 2
    -0.25
    (0.038)
    -0.32
    (0.047)
    -0.49
    (0.047)
    Month 4
    -0.35
    (0.045)
    -0.40
    (0.055)
    -0.63
    (0.055)
    Month 5
    -0.39
    (0.046)
    -0.41
    (0.056)
    -0.70
    (0.056)
    Month 6
    -0.36
    (0.049)
    -0.42
    (0.058)
    -0.69
    (0.058)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.688
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value 0.02
    Confidence Interval (2-Sided) 97.5%
    -0.11 to 0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.059
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.431
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.05
    Confidence Interval (2-Sided) 97.5%
    -0.18 to 0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.058
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.277
    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: 0.06
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -0.24
    Confidence Interval (2-Sided) 97.5%
    -0.37 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.06
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.494
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.05
    Confidence Interval (2-Sided) 97.5%
    -0.21 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.071
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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%
    -0.43 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.071
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.765
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.02
    Confidence Interval (2-Sided) 97.5%
    -0.18 to 0.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.072
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -0.31
    Confidence Interval (2-Sided) 97.5%
    -0.47 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.073
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.468
    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%
    -0.23 to 0.12
    Parameter Dispersion Type: Standard Deviation
    Value: 0.076
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -0.33
    Confidence Interval (2-Sided) 97.5%
    -0.50 to -0.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.076
    Estimation Comments
    18. Secondary Outcome
    Title Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
    Description Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
    Time Frame Baseline, Months 1, 2, 4, 5

    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 358 221 225
    Month 1
    -0.20
    (0.024)
    -0.29
    (0.031)
    -0.32
    (0.031)
    Month 2
    -0.25
    (0.026)
    -0.32
    (0.033)
    -0.44
    (0.033)
    Month 4
    -0.29
    (0.028)
    -0.38
    (0.035)
    -0.51
    (0.035)
    Month 5
    -0.32
    (0.030)
    -0.37
    (0.038)
    -0.54
    (0.038)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.029
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.09
    Confidence Interval (2-Sided) 97.5%
    -0.18 to 0.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.04
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    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 -0.11
    Confidence Interval (2-Sided) 97.5%
    -0.20 to -0.03
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.039
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.076
    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%
    -0.17 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.042
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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%
    -0.28 to -0.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.042
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    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 -0.09
    Confidence Interval (2-Sided) 97.5%
    -0.19 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.045
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.045
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.284
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.05
    Confidence Interval (2-Sided) 97.5%
    -0.16 to 0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.049
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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%
    -0.33 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.048
    Estimation Comments
    19. Secondary Outcome
    Title Patient Global Impression of Change (PGIC) Questionnaire
    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 Months 1, 2, 3, 4, 5, 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. Participants with an assessment at given time point.
    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 337 214 215
    Month 1
    3.49
    (0.062)
    3.12
    (0.078)
    2.84
    (0.077)
    Month 2
    3.24
    (0.063)
    2.62
    (0.079)
    2.15
    (0.079)
    Month 3
    3.16
    (0.066)
    2.53
    (0.083)
    2.02
    (0.083)
    Month 4
    3.19
    (0.068)
    2.56
    (0.085)
    1.97
    (0.085)
    Month 5
    3.23
    (0.070)
    2.43
    (0.088)
    1.98
    (0.088)
    Month 6
    3.22
    (0.073)
    2.50
    (0.090)
    1.95
    (0.091)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    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 -0.37
    Confidence Interval (2-Sided) 95%
    -0.56 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.099
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    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 -0.65
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.099
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    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 -0.62
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.102
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -1.09
    Confidence Interval (2-Sided) 95%
    -1.29 to -0.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.102
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    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%
    -0.84 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.106
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -1.14
    Confidence Interval (2-Sided) 95%
    -1.35 to -0.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.106
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    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 -0.62
    Confidence Interval (2-Sided) 95%
    -0.84 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.109
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -1.21
    Confidence Interval (2-Sided) 95%
    -1.43 to -1.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.109
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    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 -0.79
    Confidence Interval (2-Sided) 95%
    -1.01 to -0.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.113
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -1.24
    Confidence Interval (2-Sided) 95%
    -1.47 to -1.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.113
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    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%
    -0.95 to -0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.116
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -1.27
    Confidence Interval (2-Sided) 95%
    -1.50 to -1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.117
    Estimation Comments
    20. Secondary Outcome
    Title Change From Baseline to Each Month, Except Month 3, in NRS Scores
    Description The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
    Time Frame Baseline, Months 1, 2, 4, 5, 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 with an assessment at given time point.
    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 358 221 225
    Month 1
    -0.78
    (0.074)
    -1.06
    (0.094)
    -1.23
    (0.093)
    Month 2
    -1.08
    (0.085)
    -1.62
    (0.108)
    -2.04
    (0.107)
    Month 4
    -1.49
    (0.102)
    -2.06
    (0.128)
    -2.84
    (0.128)
    Month 5
    -1.58
    (0.105)
    -2.19
    (0.131)
    -2.95
    (0.131)
    Month 6
    -1.60
    (0.110)
    -2.28
    (0.137)
    -2.87
    (0.136)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method mixed-effects model
    Comments
    Method of Estimation Estimation Parameter LS Mean of Difference
    Estimated Value -0.28
    Confidence Interval (2-Sided) 97.5%
    -0.55 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    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 -0.45
    Confidence Interval (2-Sided) 97.5%
    -0.72 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.119
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    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 -0.54
    Confidence Interval (2-Sided) 97.5%
    -0.85 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.137
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -0.96
    Confidence Interval (2-Sided) 97.5%
    -1.27 to -0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.137
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    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 -0.58
    Confidence Interval (2-Sided) 97.5%
    -0.95 to -0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.164
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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%
    -1.72 to -0.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.164
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    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 -0.61
    Confidence Interval (2-Sided) 97.5%
    -0.99 to -0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.168
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -1.37
    Confidence Interval (2-Sided) 97.5%
    -1.75 to -1.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.168
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    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 -0.69
    Confidence Interval (2-Sided) 97.5%
    -1.08 to -0.30
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.175
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -1.28
    Confidence Interval (2-Sided) 97.5%
    -1.67 to -0.89
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.175
    Estimation Comments
    21. Secondary Outcome
    Title Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
    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, Months 1, 3, 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 with an assessment at given time point.
    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 331 213 213
    Month 1
    -15.20
    (0.971)
    -19.40
    (1.210)
    -22.75
    (1.211)
    Month 3
    -19.29
    (1.103)
    -26.62
    (1.349)
    -34.72
    (1.360)
    Month 6
    -19.53
    (1.340)
    -28.23
    (1.601)
    -36.44
    (1.572)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -7.25 to -1.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.55
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    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 -7.55
    Confidence Interval (2-Sided) 95%
    -10.6 to -4.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.55
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    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 -7.33
    Confidence Interval (2-Sided) 95%
    -10.75 to -3.91
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.74
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -15.43
    Confidence Interval (2-Sided) 95%
    -18.87 to -11.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.75
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    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 -8.7
    Confidence Interval (2-Sided) 95%
    -12.81 to -4.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.09
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -16.92
    Confidence Interval (2-Sided) 95%
    -20.98 to -12.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.07
    Estimation Comments
    22. Secondary Outcome
    Title Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
    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, Months 1, 3, 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 with an assessment at given time point.
    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 226 150 155
    Month 1
    -9.89
    (1.229)
    -10.46
    (1.510)
    -14.29
    (1.484)
    Month 3
    -14.51
    (1.502)
    -17.26
    (1.895)
    -25.20
    (1.848)
    Month 6
    -14.14
    (1.891)
    -17.07
    (2.215)
    -28.24
    (2.095)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.77
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -4.40 to 3.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.95
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -4.40
    Confidence Interval (2-Sided) 95%
    -8.19 to -0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.93
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.257
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.74
    Confidence Interval (2-Sided) 95%
    -7.50 to 2.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.42
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -10.69
    Confidence Interval (2-Sided) 95%
    -15.37 to -6.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.38
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.315
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.93
    Confidence Interval (2-Sided) 95%
    -8.66 to 2.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.91
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -14.1
    Confidence Interval (2-Sided) 95%
    -19.64 to -8.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.82
    Estimation Comments
    23. Secondary Outcome
    Title Change From Baseline to Each Month 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, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 239 150 146
    Month 1
    -0.61
    (0.267)
    -1.62
    (0.336)
    -1.56
    (0.341)
    Month 2
    -0.82
    (0.246)
    -1.80
    (0.312)
    -2.25
    (0.312)
    Month 3
    -0.76
    (0.268)
    -1.43
    (0.338)
    -2.17
    (0.336)
    Month 4
    -0.55
    (0.355)
    -1.81
    (0.434)
    -2.03
    (0.426)
    Month 5
    -0.85
    (0.209)
    -1.58
    (0.251)
    -1.96
    (0.251)
    Month 6
    -0.76
    (0.246)
    -1.34
    (0.303)
    -1.67
    (0.296)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.01
    Confidence Interval (2-Sided) 95%
    -1.86 to -0.17
    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 Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.028
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.95
    Confidence Interval (2-Sided) 95%
    -1.80 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.433
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.98
    Confidence Interval (2-Sided) 95%
    -1.76 to -0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.397
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -1.44
    Confidence Interval (2-Sided) 95%
    -2.22 to -0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.397
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.121
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.52 to 0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.432
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -1.41
    Confidence Interval (2-Sided) 95%
    -2.25 to -0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.431
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.026
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.25
    Confidence Interval (2-Sided) 95%
    -2.35 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.561
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.48
    Confidence Interval (2-Sided) 95%
    -2.57 to -0.39
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.555
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.73
    Confidence Interval (2-Sided) 95%
    -1.37 to -0.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.327
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    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 -1.11
    Confidence Interval (2-Sided) 95%
    -1.75 to -0.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.327
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.143
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -1.34 to 0.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.391
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.91
    Confidence Interval (2-Sided) 95%
    -1.67 to -0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.385
    Estimation Comments
    24. Secondary Outcome
    Title Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
    Description The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 272 178 187
    Month 1
    -1.45
    (0.261)
    -2.08
    (0.322)
    -2.30
    (0.315)
    Month 2
    -1.63
    (0.269)
    -2.75
    (0.327)
    -3.06
    (0.330)
    Month 3
    -2.03
    (0.274)
    -2.95
    (0.336)
    -2.94
    (0.333)
    Month 4
    -2.21
    (0.285)
    -2.55
    (0.353)
    -3.54
    (0.324)
    Month 5
    -1.87
    (0.284)
    -2.99
    (0.340)
    -3.51
    (0.334)
    Month 6
    -1.89
    (0.306)
    -2.61
    (0.368)
    -3.34
    (0.336)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.131
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.63
    Confidence Interval (2-Sided) 95%
    -1.44 to 0.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.415
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.037
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.85
    Confidence Interval (2-Sided) 95%
    -1.65 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.409
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.12
    Confidence Interval (2-Sided) 95%
    -1.96 to -0.29
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.423
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    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 -1.44
    Confidence Interval (2-Sided) 95%
    -2.27 to -0.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.426
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.036
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.91
    Confidence Interval (2-Sided) 95%
    -1.76 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.434
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.035
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.91
    Confidence Interval (2-Sided) 95%
    -1.76 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.431
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.452
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.34
    Confidence Interval (2-Sided) 95%
    -1.23 to 0.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.453
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -1.33
    Confidence Interval (2-Sided) 95%
    -2.18 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.432
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.12
    Confidence Interval (2-Sided) 95%
    -1.99 to -0.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.443
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.64
    Confidence Interval (2-Sided) 95%
    -2.5 to -0.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.439
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.13
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.73
    Confidence Interval (2-Sided) 95%
    -1.67 to 0.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.478
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    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 -1.45
    Confidence Interval (2-Sided) 95%
    -2.34 to -0.56
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.454
    Estimation Comments
    25. Secondary Outcome
    Title Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
    Description The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 235 145 143
    Month 1
    -1.60
    (0.623)
    -2.94
    (0.793)
    -4.69
    (0.798)
    Month 2
    -3.43
    (0.621)
    -4.74
    (0.790)
    -7.08
    (0.792)
    Month 3
    -4.07
    (0.633)
    -6.10
    (0.799)
    -7.27
    (0.801)
    Month 4
    -4.58
    (0.629)
    -6.21
    (0.774)
    -9.35
    (0.764)
    Month 5
    -4.37
    (0.618)
    -6.66
    (0.747)
    -9.51
    (0.753)
    Month 6
    -6.11
    (0.692)
    -7.08
    (0.869)
    -9.13
    (0.845)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.186
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.34
    Confidence Interval (2-Sided) 95%
    -3.32 to 0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.01
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    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 -3.09
    Confidence Interval (2-Sided) 95%
    -5.08 to -1.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.013
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.195
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.31
    Confidence Interval (2-Sided) 95%
    -3.28 to 0.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.005
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -3.65
    Confidence Interval (2-Sided) 95%
    -5.63 to -1.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.007
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    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 -2.03
    Confidence Interval (2-Sided) 95%
    -4.03 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.02
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    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 -3.2
    Confidence Interval (2-Sided) 95%
    -5.21 to -1.19
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.021
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.103
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.63
    Confidence Interval (2-Sided) 95%
    -3.59 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.998
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -4.78
    Confidence Interval (2-Sided) 95%
    -6.72 to -2.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.99
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.29
    Confidence Interval (2-Sided) 95%
    -4.20 to -0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.970
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -5.14
    Confidence Interval (2-Sided) 95%
    -7.06 to -3.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.975
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.383
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -3.16 to 1.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.112
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -3.02
    Confidence Interval (2-Sided) 95%
    -5.17 to -0.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.092
    Estimation Comments
    26. Secondary Outcome
    Title Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
    Description The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 266 175 185
    Month 1
    -0.71
    (0.266)
    -0.69
    (0.327)
    -0.72
    (0.319)
    Month 2
    -1.06
    (0.247)
    -1.28
    (0.301)
    -1.46
    (0.305)
    Month 3
    -1.31
    (0.318)
    -0.88
    (0.392)
    -1.46
    (0.392)
    Month 4
    -1.26
    (0.308)
    -1.19
    (0.383)
    -2.19
    (0.353)
    Month 5
    -0.78
    (0.406)
    -1.68
    (0.488)
    -1.69
    (0.482)
    Month 6
    -1.44
    (0.318)
    -2.27
    (0.383)
    -2.29
    (0.351)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.975
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.81 to 0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.422
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.969
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.02
    Confidence Interval (2-Sided) 95%
    -0.83 to 0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.415
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.569
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.22
    Confidence Interval (2-Sided) 95%
    -0.99 to 0.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.389
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.311
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -1.17 to 0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.393
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.398
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value 0.43
    Confidence Interval (2-Sided) 95%
    -0.56 to 1.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.505
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.761
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.15
    Confidence Interval (2-Sided) 95%
    -1.15 to 0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.505
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.874
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value 0.08
    Confidence Interval (2-Sided) 95%
    -0.89 to 1.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.491
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.048
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.93
    Confidence Interval (2-Sided) 95%
    -1.85 to -0.01
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.468
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.89
    Confidence Interval (2-Sided) 95%
    -2.14 to 0.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.635
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.152
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.9
    Confidence Interval (2-Sided) 95%
    -2.14 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.63
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.095
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.83
    Confidence Interval (2-Sided) 95%
    -1.81 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.498
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.071
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.86
    Confidence Interval (2-Sided) 95%
    -1.79 to 0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.474
    Estimation Comments
    27. Secondary Outcome
    Title Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
    Description The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 239 150 146
    Month 1
    -2.19
    (0.686)
    -4.02
    (0.865)
    -5.91
    (0.875)
    Month 2
    -4.25
    (0.674)
    -6.27
    (0.856)
    -9.36
    (0.854)
    Month 3
    -4.66
    (0.708)
    -7.31
    (0.891)
    -9.30
    (0.886)
    Month 4
    -4.87
    (0.721)
    -7.58
    (0.879)
    -11.14
    (0.862)
    Month 5
    -5.32
    (0.701)
    -7.81
    (0.839)
    -11.15
    (0.839)
    Month 6
    -6.73
    (0.793)
    -8.01
    (0.980)
    -10.70
    (0.953)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.098
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.83
    Confidence Interval (2-Sided) 95%
    -4.01 to 0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.106
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -3.72
    Confidence Interval (2-Sided) 95%
    -5.91 to -1.54
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.113
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.065
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.02
    Confidence Interval (2-Sided) 95%
    -4.16 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.091
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -5.1
    Confidence Interval (2-Sided) 95%
    -7.24 to -2.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.089
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.65
    Confidence Interval (2-Sided) 95%
    -4.89 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.14
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -4.64
    Confidence Interval (2-Sided) 95%
    -6.87 to -2.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.135
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.72
    Confidence Interval (2-Sided) 95%
    -4.95 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.138
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    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 -6.27
    Confidence Interval (2-Sided) 95%
    -8.48 to -4.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.124
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.49
    Confidence Interval (2-Sided) 95%
    -4.64 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.095
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -5.83
    Confidence Interval (2-Sided) 95%
    -7.98 to -3.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.095
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.311
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.28
    Confidence Interval (2-Sided) 95%
    -3.77 to 1.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.264
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -3.97
    Confidence Interval (2-Sided) 95%
    -6.42 to -1.53
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.241
    Estimation Comments
    28. Secondary Outcome
    Title Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
    Description The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
    Time Frame Baseline, Months 1, 2, 3, 4, 5, 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 with an assessment at given time point.
    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 272 178 187
    Month 1
    -2.18
    (0.390)
    -2.78
    (0.482)
    -2.89
    (0.470)
    Month 2
    -2.71
    (0.415)
    -4.04
    (0.503)
    -4.48
    (0.508)
    Month 3
    -3.37
    (0.448)
    -3.84
    (0.551)
    -4.34
    (0.546)
    Month 4
    -3.46
    (0.463)
    -3.77
    (0.574)
    -5.64
    (0.528)
    Month 5
    -2.62
    (0.549)
    -4.67
    (0.657)
    -5.16
    (0.646)
    Month 6
    -3.30
    (0.497)
    -4.89
    (0.598)
    -5.58
    (0.546)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.335
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -1.81 to 0.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.62
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.242
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.72
    Confidence Interval (2-Sided) 95%
    -1.91 to 0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.611
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.042
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.33
    Confidence Interval (2-Sided) 95%
    -2.61 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.652
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 2
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.77
    Confidence Interval (2-Sided) 95%
    -3.06 to -0.48
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.656
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.503
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.48
    Confidence Interval (2-Sided) 95%
    -1.87 to 0.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 3
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.169
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -2.36 to 0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.707
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.675
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -0.31
    Confidence Interval (2-Sided) 95%
    -1.76 to 1.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.737
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 4
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.17
    Confidence Interval (2-Sided) 95%
    -3.55 to -0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.703
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.04
    Confidence Interval (2-Sided) 95%
    -3.72 to -0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.856
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 5
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.54
    Confidence Interval (2-Sided) 95%
    -4.21 to -0.87
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.848
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.042
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -1.59
    Confidence Interval (2-Sided) 95%
    -3.12 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.778
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
    Comments Month 6
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LS Means
    Estimated Value -2.28
    Confidence Interval (2-Sided) 95%
    -3.73 to -0.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.738
    Estimation Comments
    29. Secondary Outcome
    Title Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
    Description This is assessed using Health Resource Utilization Questionnaire (HRUQ).
    Time Frame Months 1, 2, 3, 4, 5, 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.
    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 360 226 229
    Baseline
    99
    27.5%
    53
    23.5%
    57
    24.9%
    Month 1
    93
    25.8%
    47
    20.8%
    54
    23.6%
    Month 2
    72
    20%
    42
    18.6%
    43
    18.8%
    Month 3
    54
    15%
    46
    20.4%
    40
    17.5%
    Month 4
    62
    17.2%
    39
    17.3%
    43
    18.8%
    Month 5
    56
    15.6%
    31
    13.7%
    30
    13.1%
    Month 6
    39
    10.8%
    27
    11.9%
    25
    10.9%
    Overall
    201
    55.8%
    124
    54.9%
    131
    57.2%
    30. Secondary Outcome
    Title Number of Days of Hospitalization
    Description This is assessed using HRUQ.
    Time Frame Up to 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. Includes participants who were hospitalized during the Treatment Period.
    Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
    Arm/Group Description Placebo BID for the 6-month Treatment Period Elagolix 150 mg QD for the 6-month Treatment Period Elagolix 200 mg BID for the 6-month Treatment Period
    Measure Participants 18 16 12
    Mean (Standard Deviation) [days]
    3.2
    (2.18)
    3.3
    (3.52)
    2.2
    (1.27)
    31. Secondary Outcome
    Title Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
    Description This is assessed using HRUQ.
    Time Frame Up to 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.
    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 360 226 229
    All Categories
    37
    10.3%
    28
    12.4%
    22
    9.6%
    Abdominal Hysterectomy
    0
    0%
    0
    0%
    0
    0%
    Angiography
    0
    0%
    1
    0.4%
    0
    0%
    Arthroscopy
    0
    0%
    0
    0%
    1
    0.4%
    Biopsy
    0
    0%
    1
    0.4%
    1
    0.4%
    Blood Draw
    12
    3.3%
    13
    5.8%
    4
    1.7%
    Colposcopy
    0
    0%
    0
    0%
    0
    0%
    Consultation
    1
    0.3%
    5
    2.2%
    1
    0.4%
    CT Scan
    7
    1.9%
    10
    4.4%
    5
    2.2%
    Diagnostic Laparoscopy
    0
    0%
    0
    0%
    0
    0%
    Electrocardiogram
    4
    1.1%
    2
    0.9%
    0
    0%
    Endometrial Ablation
    0
    0%
    0
    0%
    0
    0%
    Histological Exam
    0
    0%
    0
    0%
    0
    0%
    Intrauterine Insemination
    0
    0%
    0
    0%
    0
    0%
    In Vitro Fertilization
    0
    0%
    0
    0%
    0
    0%
    Laparoscopic Hysterectomy
    0
    0%
    0
    0%
    0
    0%
    Laparotomy
    0
    0%
    0
    0%
    0
    0%
    Magnetic Resonance Imaging
    0
    0%
    2
    0.9%
    0
    0%
    Oophorectomy
    0
    0%
    0
    0%
    0
    0%
    Pelvic Exam
    3
    0.8%
    0
    0%
    2
    0.9%
    Physical Examination
    18
    5%
    16
    7.1%
    14
    6.1%
    Surgery for Adhesions
    0
    0%
    0
    0%
    0
    0%
    Therapeutic Laparoscopy
    0
    0%
    0
    0%
    0
    0%
    Transfusion
    0
    0%
    0
    0%
    0
    0%
    Ultrasound
    9
    2.5%
    3
    1.3%
    2
    0.9%
    Urine Test
    8
    2.2%
    7
    3.1%
    6
    2.6%
    Vaginal Hysterectomy
    0
    0%
    0
    0%
    0
    0%
    X-Ray
    12
    3.3%
    11
    4.9%
    7
    3.1%
    Other (Not Specified)
    13
    3.6%
    4
    1.8%
    4
    1.7%

    Adverse Events

    Time Frame From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
    Adverse Event Reporting Description
    Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
    Arm/Group Description Placebo BID for the 6-month Treatment Period Elagolix 150 mg QD for the 6-month Treatment Period Elagolix 200 mg BID for the 6-month Treatment Period
    All Cause Mortality
    Placebo Elagolix 150 mg QD Elagolix 200 mg BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/360 (0%) 1/226 (0.4%) 0/229 (0%)
    Serious Adverse Events
    Placebo Elagolix 150 mg QD Elagolix 200 mg BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/360 (3.3%) 12/226 (5.3%) 5/229 (2.2%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 3/360 (0.8%) 3 2/226 (0.9%) 2 0/229 (0%) 0
    FREQUENT BOWEL MOVEMENTS 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    LARGE INTESTINAL OBSTRUCTION 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    NAUSEA 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    Infections and infestations
    ABSCESS ORAL 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    APPENDICITIS 0/360 (0%) 0 0/226 (0%) 0 2/229 (0.9%) 2
    PHARYNGEAL ABSCESS 0/360 (0%) 0 0/226 (0%) 0 1/229 (0.4%) 1
    POSTOPERATIVE ABSCESS 0/360 (0%) 0 0/226 (0%) 0 1/229 (0.4%) 1
    URINARY TRACT INFECTION 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    Injury, poisoning and procedural complications
    LIGAMENT SPRAIN 0/360 (0%) 0 0/226 (0%) 0 1/229 (0.4%) 1
    PROCEDURAL PAIN 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN 0/360 (0%) 0 2/226 (0.9%) 2 0/229 (0%) 0
    INTERVERTEBRAL DISC PROTRUSION 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    JAW CYST 0/360 (0%) 0 0/226 (0%) 0 1/229 (0.4%) 1
    Nervous system disorders
    DIZZINESS 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    HEADACHE 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    LUMBAR RADICULOPATHY 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    SYNCOPE 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    ABORTION SPONTANEOUS 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    ABORTION SPONTANEOUS COMPLETE 2/360 (0.6%) 2 0/226 (0%) 0 0/229 (0%) 0
    Psychiatric disorders
    COMPLETED SUICIDE 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    Renal and urinary disorders
    RENAL COLIC 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    Reproductive system and breast disorders
    ENDOMETRIOSIS 1/360 (0.3%) 1 2/226 (0.9%) 2 0/229 (0%) 0
    MENORRHAGIA 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    PELVIC PAIN 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    PERINEAL PAIN 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    UTERINE POLYP 0/360 (0%) 0 2/226 (0.9%) 2 0/229 (0%) 0
    VAGINAL HAEMORRHAGE 0/360 (0%) 0 1/226 (0.4%) 1 0/229 (0%) 0
    Surgical and medical procedures
    ABORTION INDUCED 1/360 (0.3%) 1 1/226 (0.4%) 1 0/229 (0%) 0
    Vascular disorders
    BLOOD PRESSURE FLUCTUATION 1/360 (0.3%) 1 0/226 (0%) 0 0/229 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Elagolix 150 mg QD Elagolix 200 mg BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 158/360 (43.9%) 128/226 (56.6%) 162/229 (70.7%)
    Gastrointestinal disorders
    DIARRHOEA 18/360 (5%) 18 8/226 (3.5%) 8 11/229 (4.8%) 11
    NAUSEA 40/360 (11.1%) 40 26/226 (11.5%) 26 36/229 (15.7%) 36
    Infections and infestations
    NASOPHARYNGITIS 21/360 (5.8%) 21 15/226 (6.6%) 15 16/229 (7%) 16
    SINUSITIS 14/360 (3.9%) 14 10/226 (4.4%) 10 15/229 (6.6%) 15
    UPPER RESPIRATORY TRACT INFECTION 16/360 (4.4%) 16 11/226 (4.9%) 11 12/229 (5.2%) 12
    URINARY TRACT INFECTION 26/360 (7.2%) 26 10/226 (4.4%) 10 19/229 (8.3%) 19
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 11/360 (3.1%) 11 7/226 (3.1%) 7 16/229 (7%) 16
    BACK PAIN 15/360 (4.2%) 15 8/226 (3.5%) 8 13/229 (5.7%) 13
    Nervous system disorders
    HEADACHE 50/360 (13.9%) 50 42/226 (18.6%) 42 52/229 (22.7%) 52
    Psychiatric disorders
    INSOMNIA 12/360 (3.3%) 12 13/226 (5.8%) 13 24/229 (10.5%) 24
    MOOD SWINGS 8/360 (2.2%) 8 13/226 (5.8%) 13 6/229 (2.6%) 6
    Reproductive system and breast disorders
    AMENORRHOEA 1/360 (0.3%) 1 11/226 (4.9%) 11 20/229 (8.7%) 20
    Vascular disorders
    HOT FLUSH 37/360 (10.3%) 37 51/226 (22.6%) 51 109/229 (47.6%) 109

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie
    Phone 800-633-9110
    Email abbvieclinicaltrials@abbvie.com
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01931670
    Other Study ID Numbers:
    • M12-671
    • 2011-004295-11
    First Posted:
    Aug 29, 2013
    Last Update Posted:
    Sep 7, 2018
    Last Verified:
    Mar 1, 2018