CClinicalTrials.gg
Sign In
CompletedNCT01931670ELARIS EM-IIUpdated Sep 7, 2018Results posted

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

A Phase 3 interventional study of placebo and Elagolix in Endometriosis, sponsored by AbbVie. Completed. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
815
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Endometriosis

Browse trials for

Keywords

  • Non-Menstrual Pelvic Pain (NMPP)
  • Dysmenorrhea (DYS)
  • Elagolix
  • Endometriosis Associated Pain
  • Gonadotropin-Releasing Hormone Antagonist
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 815 is above the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
815 participants (actual)

Study arms

  • 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

  • Experimental
    Elagolix 200 mg BID

    Elagolix 200 mg BID for the 6-month Treatment Period

    Drug: Elagolix

Interventions

  • Otherplacebo
  • DrugElagolix

    Also known as: ABT-620, elagolix sodium

06

What researchers measure

Primary outcomes

  1. Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)

    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

  2. Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)

    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

Secondary outcomes

  1. Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores

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

    Time frame: Baseline, Month 3 of the Treatment Period

  2. Change From Baseline to Month 6 in DYS

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

    Time frame: Baseline, Month 6 of Treatment Period

  3. Change From Baseline to Month 6 in NMPP

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

    Time frame: Baseline, Month 6 of Treatment Period

  4. Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics

    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

  5. Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics

    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

  6. Change From Baseline to Month 3 in Dyspareunia (DYSP)

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

    Time frame: Baseline, Month 3 of Treatment Period

  7. Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)

    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

  8. Percentage of Responders for Each Month, Except Month 3, in DYS

    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

  9. Percentage of Responders for Each Month, Except Month 3, in NMPP

    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

  10. Percentage of Responders at Each Month for DYSP

    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

  11. Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS

    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

  12. Percent Change From Baseline to Each Month in Mean Pain Score for DYS

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

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

  13. Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP

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

    Time frame: Baseline, Months 1, 2, 3, 4, 5 of Treatment Period

  14. Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP

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

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

  15. Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP

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

    Time frame: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period

  16. Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics

    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

  17. Patient Global Impression of Change (PGIC) Questionnaire

    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

  18. Change From Baseline to Each Month, Except Month 3, in NRS Scores

    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

  19. Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores

    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

  20. Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores

    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

  21. Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism

    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

  22. Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

    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

  23. Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

    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

  24. Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

    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

  25. Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

    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

  26. Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

    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

  27. Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period

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

    Time frame: Months 1, 2, 3, 4, 5, 6 of Treatment Period

  28. Number of Days of Hospitalization

    This is assessed using HRUQ.

    Time frame: Up to Month 6 of Treatment Period

  29. Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type

    This is assessed using HRUQ.

    Time frame: Up to Month 6 of Treatment Period

07

Results

Posted Sep 7, 2018

Participant flow

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.

Treatment Period
Participant flow — Treatment Period
MilestonePlaceboElagolix 150 mg QDElagolix 200 mg BID
Started360226229
Completed270178184
Not completed904845
Withdrew: Exclusionary medication received111
Withdrew: Surgery/invasive intervention420
Withdrew: Subject noncompliant495
Withdrew: Adverse event19821
Withdrew: Lack of efficacy1122
Withdrew: Pregnancy720
Withdrew: Other872
Withdrew: Consent withdrawn by subject17127
Withdrew: Lost to follow-up1957
Post-Treatment Follow-Up (PTFU) Period
Participant flow — Post-Treatment Follow-Up (PTFU) Period
MilestonePlaceboElagolix 150 mg QDElagolix 200 mg BID
Started614054
Completed ptfu month 6422418
Completed ptfu month 120415
Completed422833
Not completed191221
Withdrew: Exclusionary medication received300
Withdrew: Adverse event021
Withdrew: Surgery/invasive intervention442
Withdrew: Other633
Withdrew: Consent withdrawn by subject6313
Withdrew: Lost to follow-up002

Outcome measures

PrimaryPercentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)

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
Reported as:
Number · percentage of participants
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
percentage of participantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)22.743.472.4
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = < 0.001 (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.)
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 (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.)
PrimaryPercentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)

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
Reported as:
Number · percentage of participants
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
percentage of participantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)36.549.857.8
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.003 (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.)
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 (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.)
SecondaryChange From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores

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

Time frame:
Baseline, Month 3 of the Treatment Period
Reported as:
Least squares mean · units on a scale
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores-1.33 ± 0.097-1.90 ± 0.122-2.55 ± 0.122
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = <0.001 (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.) · Difference in ls mean change: -0.57
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -1.22
SecondaryChange From Baseline to Month 6 in DYS

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

Time frame:
Baseline, Month 6 of Treatment Period
Reported as:
Least squares mean · units on a scale
Change From Baseline to Month 6 in DYS
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 6 in DYS-0.52 ± 0.047-1.06 ± 0.057-1.65 ± 0.057
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -0.54
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -1.13
SecondaryChange From Baseline to Month 6 in NMPP

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

Time frame:
Baseline, Month 6 of Treatment Period
Reported as:
Least squares mean · units on a scale
Change From Baseline to Month 6 in NMPP
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 6 in NMPP-0.48 ± 0.035-0.63 ± 0.044-0.80 ± 0.044
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.009 (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.) · Difference in ls mean change: -0.15
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -0.32
SecondaryChange From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics

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
Reported as:
Least squares mean · number of pills
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
number of pillsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics-0.31 ± 0.028-0.36 ± 0.035-0.49 ± 0.034
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.26 (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.) · Difference in ls mean change: -0.05
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -0.18
SecondaryChange From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics

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
Reported as:
Least squares mean · number of pills
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
number of pillsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics-0.32 ± 0.030-0.40 ± 0.038-0.52 ± 0.037
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.088 (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.) · Difference in ls mean change: -0.08
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -0.21
SecondaryChange From Baseline to Month 3 in Dyspareunia (DYSP)

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

Time frame:
Baseline, Month 3 of Treatment Period
Reported as:
Least squares mean · units on a scale
Change From Baseline to Month 3 in Dyspareunia (DYSP)
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 3 in Dyspareunia (DYSP)-0.30 ± 0.042-0.39 ± 0.052-0.60 ± 0.052
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.172 (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.) · Difference in ls mean change: -0.09
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 (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.) · Difference in ls mean change: -0.30
SecondaryChange From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)

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
Reported as:
Least squares mean · number of pills
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
number of pillsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)-0.12 ± 0.019-0.12 ± 0.024-0.21 ± 0.023
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.968 (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.) · Difference in ls mean change: 0.00
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = 0.007 (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.) · Difference in ls mean change: -0.08
SecondaryPercentage of Responders for Each Month, Except Month 3, in DYS

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
Reported as:
Number · percentage of participants
Percentage of Responders for Each Month, Except Month 3, in DYS
percentage of participantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Month 117.333.046.2
Month 219.039.469.8
Month 421.245.979.8
Month 523.744.180.7
Month 625.446.276.9
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.361 · 97.5% CI 1.507 to 3.697
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 4.185 · 97.5% CI 2.707 to 6.469
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.795 · 97.5% CI 1.811 to 4.312
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 10.378 · 97.5% CI 6.615 to 16.282
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = < 0.001 · Odds ratio (or): 3.178 · 97.5% CI 2.084 to 4.845
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 15.216 · 97.5% CI 9.429 to 24.554
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.548 · 97.5% CI 1.683 to 3.859
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 14.055 · 97.5% CI 8.716 to 22.664
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.536 · 97.5% CI 1.685 to 3.816
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 10.106 · 97.5% CI 6.434 to 15.874
SecondaryPercentage of Responders for Each Month, Except Month 3, in NMPP

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
Reported as:
Number · percentage of participants
Percentage of Responders for Each Month, Except Month 3, in NMPP
percentage of participantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Month 123.527.629.3
Month 232.139.850.7
Month 438.751.463.2
Month 539.850.563.2
Month 640.651.662.2
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.376 · Odds ratio (or): 1.191 · 97.5% CI 0.765 to 1.855
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = 0.101 · Odds ratio (or): 1.376 · 97.5% CI 0.890 to 2.127
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.088 · Odds ratio (or): 1.358 · 97.5% CI 0.909 to 2.029
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.208 · 97.5% CI 1.488 to 3.278
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.003 · Odds ratio (or): 1.678 · 97.5% CI 1.136 to 2.477
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.722 · 97.5% CI 1.832 to 4.044
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.013 · Odds ratio (or): 1.537 · 97.5% CI 1.042 to 2.267
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.598 · 97.5% CI 1.750 to 3.857
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.01 · Odds ratio (or): 1.565 · 97.5% CI 1.062 to 2.306
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.412 · 97.5% CI 1.630 to 3.570
SecondaryPercentage of Responders at Each Month for DYSP

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
Reported as:
Number · percentage of participants
Percentage of Responders at Each Month for DYSP
percentage of participantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Month 133.333.835.1
Month 233.239.947.4
Month 339.544.053.7
Month 438.541.359.8
Month 537.442.858.1
Month 639.439.955.8
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.901 · Odds ratio (or): 1.028 · 97.5% CI 0.624 to 1.693
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = 0.65 · Odds ratio (or): 1.103 · 97.5% CI 0.680 to 1.789
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.154 · Odds ratio (or): 1.351 · 97.5% CI 0.841 to 2.170
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = 0.003 · Odds ratio (or): 1.871 · 97.5% CI 1.175 to 2.979
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.294 · Odds ratio (or): 1.250 · 97.5% CI 0.776 to 2.013
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = 0.003 · Odds ratio (or): 1.865 · 97.5% CI 1.163 to 2.989
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.521 · Odds ratio (or): 1.145 · 97.5% CI 0.713 to 1.839
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.474 · 97.5% CI 1.544 to 3.963
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.27 · Odds ratio (or): 1.262 · 97.5% CI 0.787 to 2.023
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 2.416 · 97.5% CI 1.500 to 3.891
  • Placebo vs Elagolix 150 mg QD · Regression, Logistic · p = 0.953 · Odds ratio (or): 1.013 · 97.5% CI 0.631 to 1.624
  • Placebo vs Elagolix 200 mg BID · Regression, Logistic · p = < 0.001 · Odds ratio (or): 1.997 · 97.5% CI 1.253 to 3.183
SecondaryChange From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS

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
Reported as:
Least squares mean · units on a scale
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.53 · 97.5% CI -0.69 to -0.37
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.78 · 97.5% CI -0.94 to -0.62
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.44 · 97.5% CI -0.6 to -0.29
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.27 · 97.5% CI -1.43 to -1.12
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.53 · 97.5% CI -0.68 to -0.37
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.25 · 97.5% CI -1.4 to -1.09
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.58 · 97.5% CI -0.73 to -0.42
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.27 · 97.5% CI -1.42 to -1.11
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.49 · 97.5% CI -0.65 to -0.33
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.26 · 97.5% CI -1.42 to -1.10
SecondaryPercent Change From Baseline to Each Month in Mean Pain Score for DYS

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

Time frame:
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Reported as:
Least squares mean · percentage change
Percent Change From Baseline to Each Month in Mean Pain Score for DYS
percentage changePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -25.31 · 97.5% CI -33.55 to -17.07
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -39.32 · 97.5% CI -47.53 to -31.11
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -21.9 · 97.5% CI -29.44 to -14.36
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -63.31 · 97.5% CI -70.87 to -55.76
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -25.15 · 97.5% CI -32.43 to -17.88
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -61.94 · 97.5% CI -69.20 to -54.68
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -26.97 · 97.5% CI -34.48 to -19.46
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -62.37 · 97.5% CI -69.89 to -54.86
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -23.36 · 97.5% CI -31.06 to -15.66
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -62.9 · 97.5% CI -70.58 to -55.22
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -25.89 · 97.5% CI -33.81 to -17.97
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -56.62 · 97.5% CI -64.53 to -48.70
SecondaryChange From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP

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

Time frame:
Baseline, Months 1, 2, 3, 4, 5 of Treatment Period
Reported as:
Least squares mean · units on a scale
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.549 · Ls mean of difference: -0.02 · 97.5% CI -0.11 to 0.07
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = 0.02 · Ls mean of difference: -0.09 · 97.5% CI -0.18 to 0.00
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.11 · Ls mean of difference: -0.07 · 97.5% CI -0.17 to 0.03
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.20 · 97.5% CI -0.30 to -0.11
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.041 · Ls mean of difference: -0.10 · 97.5% CI -0.22 to 0.01
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.29 · 97.5% CI -0.41 to -0.18
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.081 · Ls mean of difference: -0.09 · 97.5% CI -0.21 to 0.03
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = <0.001 · Ls mean of difference: -0.33 · 97.5% CI -0.45 to -0.22
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.062 · Ls mean of difference: -0.10 · 97.5% CI -0.22 to 0.02
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.34 · 97.5% CI -0.46 to -0.22
SecondaryPercent Change From Baseline to Each Month in the Mean Pain Score for NMPP

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

Time frame:
Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Reported as:
Least squares mean · percentage change
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
percentage changePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.301 · Ls mean of difference: -3.04 · 97.5% CI -9.64 to 3.56
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = 0.028 · Ls mean of difference: -6.43 · 97.5% CI -12.99 to 0.13
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.082 · Ls mean of difference: -5.17 · 97.5% CI -11.82 to 1.49
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -13.19 · 97.5% CI -19.83 to -6.55
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.043 · Ls mean of difference: -6.84 · 97.5% CI -14.43 to 0.75
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -19.05 · 97.5% CI -26.61 to -11.49
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.072 · Ls mean of difference: -6.25 · 97.5% CI -14.05 to 1.55
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -21.58 · 97.5% CI -29.35 to -13.81
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.08 · Ls mean of difference: -6.21 · 97.5% CI -14.15 to 1.73
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -21.66 · 97.5% CI -29.56 to -13.75
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.004 · Ls mean of difference: -10.83 · 97.5% CI -19.24 to -2.43
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -21.16 · 97.5% CI -29.54 to -12.79
SecondaryChange From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP

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

Time frame:
Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
Reported as:
Least squares mean · units on a scale
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.688 · Ls mean of difference: 0.02 · 97.5% CI -0.11 to 0.16
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = 0.431 · Ls mean of difference: -0.05 · 97.5% CI -0.18 to 0.08
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.277 · Ls mean of difference: -0.07 · 97.5% CI -0.20 to 0.07
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.24 · 97.5% CI -0.37 to -0.10
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.494 · Ls mean of difference: -0.05 · 97.5% CI -0.21 to 0.11
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.27 · 97.5% CI -0.43 to -0.11
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.765 · Ls mean of difference: -0.02 · 97.5% CI -0.18 to 0.14
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.31 · 97.5% CI -0.47 to -0.15
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.468 · Ls mean of difference: -0.06 · 97.5% CI -0.23 to 0.12
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.33 · 97.5% CI -0.50 to -0.16
SecondaryChange From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics

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
Reported as:
Least squares mean · number of pills
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
number of pillsPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.029 · Ls mean of difference: -0.09 · 97.5% CI -0.18 to 0.00
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = 0.004 · Ls mean of difference: -0.11 · 97.5% CI -0.20 to -0.03
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.076 · Ls mean of difference: -0.08 · 97.5% CI -0.17 to 0.02
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.19 · 97.5% CI -0.28 to -0.09
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.058 · Ls mean of difference: -0.09 · 97.5% CI -0.19 to 0.02
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.22 · 97.5% CI -0.32 to -0.12
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.284 · Ls mean of difference: -0.05 · 97.5% CI -0.16 to 0.06
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.22 · 97.5% CI -0.33 to -0.11
SecondaryPatient Global Impression of Change (PGIC) Questionnaire

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
Reported as:
Least squares mean · units on a scale
Patient Global Impression of Change (PGIC) Questionnaire
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
Month 13.49 ± 0.0623.12 ± 0.0782.84 ± 0.077
Month 23.24 ± 0.0632.62 ± 0.0792.15 ± 0.079
Month 33.16 ± 0.0662.53 ± 0.0832.02 ± 0.083
Month 43.19 ± 0.0682.56 ± 0.0851.97 ± 0.085
Month 53.23 ± 0.0702.43 ± 0.0881.98 ± 0.088
Month 63.22 ± 0.0732.50 ± 0.0901.95 ± 0.091
Statistical analysis
  • Placebo vs Elagolix 150 mg QD · ANOVA · p = < 0.001 · Ls mean of difference: -0.37 · 95% CI -0.56 to -0.18
  • Placebo vs Elagolix 200 mg BID · ANOVA · p = < 0.001 · Ls mean of difference: -0.65 · 95% CI -0.84 to -0.46
  • Placebo vs Elagolix 150 mg QD · ANOVA · p = < 0.001 · Ls mean of difference: -0.62 · 95% CI -0.82 to -0.42
  • Placebo vs Elagolix 200 mg BID · ANOVA · p = < 0.001 · Ls mean of difference: -1.09 · 95% CI -1.29 to -0.89
  • Placebo vs Elagolix 150 mg QD · ANOVA · p = < 0.001 · Ls mean of difference: -0.63 · 95% CI -0.84 to -0.42
  • Placebo vs Elagolix 200 mg BID · ANOVA · p = < 0.001 · Ls mean of difference: -1.14 · 95% CI -1.35 to -0.93
  • Placebo vs Elagolix 150 mg QD · ANOVA · p = < 0.001 · Ls mean of difference: -0.62 · 95% CI -0.84 to -0.41
  • Placebo vs Elagolix 200 mg BID · ANOVA · p = < 0.001 · Ls mean of difference: -1.21 · 95% CI -1.43 to -1.00
  • Placebo vs Elagolix 150 mg QD · ANOVA · p = < 0.001 · Ls mean of difference: -0.79 · 95% CI -1.01 to -0.57
  • Placebo vs Elagolix 200 mg BID · ANOVA · p = < 0.001 · Ls mean of difference: -1.24 · 95% CI -1.47 to -1.02
  • Placebo vs Elagolix 150 mg QD · ANOVA · p = < 0.001 · Ls mean of difference: -0.72 · 95% CI -0.95 to -0.49
  • Placebo vs Elagolix 200 mg BID · ANOVA · p = < 0.001 · Ls mean of difference: -1.27 · 95% CI -1.50 to -1.04
SecondaryChange From Baseline to Each Month, Except Month 3, in NRS Scores

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
Reported as:
Least squares mean · units on a scale
Change From Baseline to Each Month, Except Month 3, in NRS Scores
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = 0.02 · Ls mean of difference: -0.28 · 97.5% CI -0.55 to -0.01
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.45 · 97.5% CI -0.72 to -0.18
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.54 · 97.5% CI -0.85 to -0.23
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.96 · 97.5% CI -1.27 to -0.65
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.58 · 97.5% CI -0.95 to -0.21
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.36 · 97.5% CI -1.72 to -0.99
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.61 · 97.5% CI -0.99 to -0.23
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.37 · 97.5% CI -1.75 to -1.00
  • Placebo vs Elagolix 150 mg QD · mixed-effects model · p = < 0.001 · Ls mean of difference: -0.69 · 97.5% CI -1.08 to -0.30
  • Placebo vs Elagolix 200 mg BID · mixed-effects model · p = < 0.001 · Ls mean of difference: -1.28 · 97.5% CI -1.67 to -0.89
SecondaryChange From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores

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
Reported as:
Least squares mean · units on a scale
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.007 · Difference in ls means: -4.2 · 95% CI -7.25 to -1.16
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -7.55 · 95% CI -10.6 to -4.50
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = < 0.001 · Difference in ls means: -7.33 · 95% CI -10.75 to -3.91
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -15.43 · 95% CI -18.87 to -11.99
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = < 0.001 · Difference in ls means: -8.7 · 95% CI -12.81 to -4.60
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -16.92 · 95% CI -20.98 to -12.86
SecondaryChange From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores

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
Reported as:
Least squares mean · units on a scale
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores
units on a scalePlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.77 · Difference in ls means: -0.57 · 95% CI -4.40 to 3.26
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.023 · Difference in ls means: -4.40 · 95% CI -8.19 to -0.61
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.257 · Difference in ls means: -2.74 · 95% CI -7.50 to 2.01
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -10.69 · 95% CI -15.37 to -6.01
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.315 · Difference in ls means: -2.93 · 95% CI -8.66 to 2.80
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -14.1 · 95% CI -19.64 to -8.55
SecondaryChange From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism

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
Reported as:
Least squares mean · hours
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
hoursPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.019 · Difference in ls means: -1.01 · 95% CI -1.86 to -0.17
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.028 · Difference in ls means: -0.95 · 95% CI -1.80 to -0.10
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.014 · Difference in ls means: -0.98 · 95% CI -1.76 to -0.20
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -1.44 · 95% CI -2.22 to -0.65
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.121 · Difference in ls means: -0.67 · 95% CI -1.52 to 0.18
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.001 · Difference in ls means: -1.41 · 95% CI -2.25 to -0.56
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.026 · Difference in ls means: -1.25 · 95% CI -2.35 to -0.15
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.008 · Difference in ls means: -1.48 · 95% CI -2.57 to -0.39
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.027 · Difference in ls means: -0.73 · 95% CI -1.37 to -0.08
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -1.11 · 95% CI -1.75 to -0.47
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.143 · Difference in ls means: -0.57 · 95% CI -1.34 to 0.20
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.019 · Difference in ls means: -0.91 · 95% CI -1.67 to -0.15
SecondaryChange From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism

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
Reported as:
Least squares mean · hours
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
hoursPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.131 · Difference in ls means: -0.63 · 95% CI -1.44 to 0.19
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.037 · Difference in ls means: -0.85 · 95% CI -1.65 to -0.05
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.008 · Difference in ls means: -1.12 · 95% CI -1.96 to -0.29
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -1.44 · 95% CI -2.27 to -0.60
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.036 · Difference in ls means: -0.91 · 95% CI -1.76 to -0.06
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.035 · Difference in ls means: -0.91 · 95% CI -1.76 to -0.06
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.452 · Difference in ls means: -0.34 · 95% CI -1.23 to 0.55
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.002 · Difference in ls means: -1.33 · 95% CI -2.18 to -0.48
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.012 · Difference in ls means: -1.12 · 95% CI -1.99 to -0.25
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -1.64 · 95% CI -2.5 to -0.78
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.13 · Difference in ls means: -0.73 · 95% CI -1.67 to 0.21
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.001 · Difference in ls means: -1.45 · 95% CI -2.34 to -0.56
SecondaryChange From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism

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
Reported as:
Least squares mean · hours
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
hoursPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.186 · Difference in ls means: -1.34 · 95% CI -3.32 to 0.65
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.002 · Difference in ls means: -3.09 · 95% CI -5.08 to -1.10
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.195 · Difference in ls means: -1.31 · 95% CI -3.28 to 0.67
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -3.65 · 95% CI -5.63 to -1.67
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.047 · Difference in ls means: -2.03 · 95% CI -4.03 to -0.02
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.002 · Difference in ls means: -3.2 · 95% CI -5.21 to -1.19
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.103 · Difference in ls means: -1.63 · 95% CI -3.59 to 0.33
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -4.78 · 95% CI -6.72 to -2.83
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.019 · Difference in ls means: -2.29 · 95% CI -4.20 to -0.38
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -5.14 · 95% CI -7.06 to -3.22
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.383 · Difference in ls means: -0.97 · 95% CI -3.16 to 1.22
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.006 · Difference in ls means: -3.02 · 95% CI -5.17 to -0.87
SecondaryChange From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism

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
Reported as:
Least squares mean · hours
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
hoursPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.975 · Difference in ls means: 0.01 · 95% CI -0.81 to 0.84
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.969 · Difference in ls means: -0.02 · 95% CI -0.83 to 0.80
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.569 · Difference in ls means: -0.22 · 95% CI -0.99 to 0.54
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.311 · Difference in ls means: -0.4 · 95% CI -1.17 to 0.37
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.398 · Difference in ls means: 0.43 · 95% CI -0.56 to 1.42
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.761 · Difference in ls means: -0.15 · 95% CI -1.15 to 0.84
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.874 · Difference in ls means: 0.08 · 95% CI -0.89 to 1.04
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.048 · Difference in ls means: -0.93 · 95% CI -1.85 to -0.01
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.16 · Difference in ls means: -0.89 · 95% CI -2.14 to 0.35
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.152 · Difference in ls means: -0.9 · 95% CI -2.14 to 0.33
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.095 · Difference in ls means: -0.83 · 95% CI -1.81 to 0.15
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.071 · Difference in ls means: -0.86 · 95% CI -1.79 to 0.07
SecondaryChange From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace

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
Reported as:
Least squares mean · hours
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
hoursPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.098 · Difference in ls means: -1.83 · 95% CI -4.01 to 0.34
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -3.72 · 95% CI -5.91 to -1.54
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.065 · Difference in ls means: -2.02 · 95% CI -4.16 to 0.13
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -5.1 · 95% CI -7.24 to -2.96
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.02 · Difference in ls means: -2.65 · 95% CI -4.89 to -0.41
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -4.64 · 95% CI -6.87 to -2.41
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.017 · Difference in ls means: -2.72 · 95% CI -4.95 to -0.48
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -6.27 · 95% CI -8.48 to -4.06
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.023 · Difference in ls means: -2.49 · 95% CI -4.64 to -0.34
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = < 0.001 · Difference in ls means: -5.83 · 95% CI -7.98 to -3.68
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.311 · Difference in ls means: -1.28 · 95% CI -3.77 to 1.20
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.001 · Difference in ls means: -3.97 · 95% CI -6.42 to -1.53
SecondaryChange From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household

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
Reported as:
Least squares mean · hours
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
hoursPlaceboElagolix 150 mg QDElagolix 200 mg BID
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
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.335 · Difference in ls means: -0.60 · 95% CI -1.81 to 0.62
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.242 · Difference in ls means: -0.72 · 95% CI -1.91 to 0.48
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.042 · Difference in ls means: -1.33 · 95% CI -2.61 to -0.05
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.007 · Difference in ls means: -1.77 · 95% CI -3.06 to -0.48
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.503 · Difference in ls means: -0.48 · 95% CI -1.87 to 0.92
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.169 · Difference in ls means: -0.97 · 95% CI -2.36 to 0.41
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.675 · Difference in ls means: -0.31 · 95% CI -1.76 to 1.14
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.002 · Difference in ls means: -2.17 · 95% CI -3.55 to -0.79
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.017 · Difference in ls means: -2.04 · 95% CI -3.72 to -0.36
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.003 · Difference in ls means: -2.54 · 95% CI -4.21 to -0.87
  • Placebo vs Elagolix 150 mg QD · ANCOVA · p = 0.042 · Difference in ls means: -1.59 · 95% CI -3.12 to -0.06
  • Placebo vs Elagolix 200 mg BID · ANCOVA · p = 0.002 · Difference in ls means: -2.28 · 95% CI -3.73 to -0.83
SecondaryNumber of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period

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

Time frame:
Months 1, 2, 3, 4, 5, 6 of Treatment Period
Reported as:
Count of participants · Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
ParticipantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
Baseline995357
Month 1934754
Month 2724243
Month 3544640
Month 4623943
Month 5563130
Month 6392725
Overall201124131
SecondaryNumber of Days of Hospitalization

This is assessed using HRUQ.

Time frame:
Up to Month 6 of Treatment Period
Reported as:
Mean · days
Number of Days of Hospitalization
daysPlaceboElagolix 150 mg QDElagolix 200 mg BID
Number of Days of Hospitalization3.2 ± 2.183.3 ± 3.522.2 ± 1.27
SecondaryNumber of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type

This is assessed using HRUQ.

Time frame:
Up to Month 6 of Treatment Period
Reported as:
Count of participants · Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
ParticipantsPlaceboElagolix 150 mg QDElagolix 200 mg BID
All Categories372822
Abdominal Hysterectomy000
Angiography010
Arthroscopy001
Biopsy011
Blood Draw12134
Colposcopy000
Consultation151
CT Scan7105
Diagnostic Laparoscopy000
Electrocardiogram420
Endometrial Ablation000
Histological Exam000
Intrauterine Insemination000
In Vitro Fertilization000
Laparoscopic Hysterectomy000
Laparotomy000
Magnetic Resonance Imaging020
Oophorectomy000
Pelvic Exam302
Physical Examination181614
Surgery for Adhesions000
Therapeutic Laparoscopy000
Transfusion000
Ultrasound932
Urine Test876
Vaginal Hysterectomy000
X-Ray12117
Other (Not Specified)1344

Adverse events

Collected over From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/360 (0%)12/360 (3.3%)158/360 (43.9%)
Elagolix 150 mg QD1/226 (0.4%)12/226 (5.3%)128/226 (56.6%)
Elagolix 200 mg BID0/229 (0%)5/229 (2.2%)162/229 (70.7%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventPlaceboElagolix 150 mg QDElagolix 200 mg BID
ABDOMINAL PAINGastrointestinal disorders3/3602/2260/229
BACK PAINMusculoskeletal and connective tissue disorders0/3602/2260/229
ENDOMETRIOSISReproductive system and breast disorders1/3602/2260/229
UTERINE POLYPReproductive system and breast disorders0/3602/2260/229
APPENDICITISInfections and infestations0/3600/2262/229
ABORTION SPONTANEOUS COMPLETEPregnancy, puerperium and perinatal conditions2/3600/2260/229
FREQUENT BOWEL MOVEMENTSGastrointestinal disorders0/3601/2260/229
ABSCESS ORALInfections and infestations0/3601/2260/229
PROCEDURAL PAINInjury, poisoning and procedural complications0/3601/2260/229
INTERVERTEBRAL DISC PROTRUSIONMusculoskeletal and connective tissue disorders0/3601/2260/229
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPlaceboElagolix 150 mg QDElagolix 200 mg BID
HOT FLUSHVascular disorders37/36051/226109/229
HEADACHENervous system disorders50/36042/22652/229
NAUSEAGastrointestinal disorders40/36026/22636/229
INSOMNIAPsychiatric disorders12/36013/22624/229
AMENORRHOEAReproductive system and breast disorders1/36011/22620/229
URINARY TRACT INFECTIONInfections and infestations26/36010/22619/229
NASOPHARYNGITISInfections and infestations21/36015/22616/229
ARTHRALGIAMusculoskeletal and connective tissue disorders11/3607/22616/229
SINUSITISInfections and infestations14/36010/22615/229
MOOD SWINGSPsychiatric disorders8/36013/2266/229

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboElagolix 150 mg QDElagolix 200 mg BIDTotal
Mean33.1 ± 6.6933.1 ± 6.8033.4 ± 6.6733.2 ± 6.71
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboElagolix 150 mg QDElagolix 200 mg BIDTotal
Female360226229815
Male0000
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. PubMed 28525302 ↗
  • Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8. PubMed 34878624 ↗
  • Abrao MS, Surrey E, Gordon K, Snabes MC, Wang H, Ijacu H, Taylor HS. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021 Jun 16;21(1):246. doi: 10.1186/s12905-021-01385-3. PubMed 34134684 ↗
  • Stodtmann S, Nader A, Polepally AR, Suleiman AA, Winzenborg I, Noertersheuser P, Ng J, Mostafa NM, Shebley M. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis. Clin Transl Sci. 2021 Jul;14(4):1611-1619. doi: 10.1111/cts.13040. Epub 2021 May 7. PubMed 33963686 ↗
  • Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8. Erratum In: Clin Transl Sci. 2022 Mar;15(3):799. doi: 10.1111/cts.13188. PubMed 33650259 ↗
  • Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021. PubMed 33564263 ↗
  • Pokrzywinski RM, Soliman AM, Snabes MC, Chen J, Taylor HS, Coyne KS. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis. Fertil Steril. 2021 Feb;115(2):423-430. doi: 10.1016/j.fertnstert.2020.07.013. Epub 2020 Oct 14. PubMed 33066973 ↗
  • Abbas Suleiman A, Nader A, Winzenborg I, Beck D, Polepally AR, Ng J, Noertersheuser P, Mostafa NM. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain. CPT Pharmacometrics Syst Pharmacol. 2020 Nov;9(11):639-648. doi: 10.1002/psp4.12560. Epub 2020 Oct 8. PubMed 32945631 ↗
  • Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917. PubMed 32769633 ↗
  • Winzenborg I, Polepally AR, Nader A, Mostafa NM, Noertersheuser P, Ng J. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model. CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):466-475. doi: 10.1002/psp4.12545. Epub 2020 Jul 31. PubMed 32621325 ↗
  • Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7. PubMed 31654294 ↗
  • Pokrzywinski RM, Soliman AM, Chen J, Snabes M, Diamond MP, Surrey E, Coyne KS. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials. Fertil Steril. 2019 Sep;112(3):545-551. doi: 10.1016/j.fertnstert.2019.04.031. Epub 2019 Jun 18. Erratum In: Fertil Steril. 2020 Jan;113(1):237. doi: 10.1016/j.fertnstert.2019.10.032. PubMed 31227284 ↗
  • Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019. PubMed 31069056 ↗
  • Wang ST, Johnson SJ, Mitchell D, Soliman AM, Vora JB, Agarwal SK. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA. J Comp Eff Res. 2019 Apr;8(5):337-355. doi: 10.2217/cer-2018-0124. Epub 2019 Feb 6. PubMed 30724096 ↗
  • Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6. PubMed 29476499 ↗

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01931670
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Aug 29, 2013
Start date
Sep 9, 2013
Primary completion
Jan 6, 2016
Completion
Dec 19, 2016
Results posted
Sep 7, 2018
Last update
Sep 7, 2018

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Endometriosis→

Other studies from this sponsor

AbbVie

Start the discussion