Phase 3
N=872
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT01620528 ↗Enrolled (actual)
872
Serious AEs
2.4%
Results posted
Sep 2018
Primary outcome: Primary: Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) — 19.6; 46.4; 75.8 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- elagolix (Drug); placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) |
19.6; 46.4; 75.8 | < 0.001 sig |
| PRIMARY Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) |
36.5; 50.4; 54.5 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores |
-1.09; -1.74; -2.39 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 6 in DYS |
-0.44; -0.89; -1.75 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 6 in NMPP |
-0.31; -0.48; -0.72 | 0.004 sig |
| SECONDARY Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.29; -0.29; -0.55 | 0.910 |
| SECONDARY Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.27; -0.35; -0.56 | 0.185 |
| SECONDARY Change From Baseline to Month 3 in Dyspareunia (DYSP) |
-0.29; -0.39; -0.49 | 0.144 |
| SECONDARY Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) |
-0.10; -0.07; -0.22 | 0.424 |
| SECONDARY Percentage of Responders at Month 1 Based on Daily Assessment of DYS |
14.5; 35.1; 44.1 | < 0.001 sig |
| SECONDARY Percentage of Responders at Month 2 Based on Daily Assessment of DYS |
17.2; 44.8; 71.3 | < 0.001 sig |
| SECONDARY Percentage of Responders at Month 4 Based on Daily Assessment of DYS |
21.7; 47.6; 75.3 | < 0.001 sig |
| SECONDARY Percentage of Responders at Month 5 Based on Daily Assessment of DYS |
24.3; 45.7; 79.0 | < 0.001 sig |
| SECONDARY Percentage of Responders at Month 6 Based on Daily Assessment of DYS |
23.1; 42.1; 75.3 | < 0.001 sig |
| SECONDARY Percentage of Responders at Month 1 Based on Daily Assessment of NMPP |
25.8; 32.3; 33.9 | 0.103 |
| SECONDARY Percentage of Responders at Month 2 Based on Daily Assessment of NMPP |
32.2; 41.1; 46.3 | 0.031 sig |
| SECONDARY Percentage of Responders at Month 4 Based on Daily Assessment of NMPP |
35.4; 53.2; 63.8 | < 0.001 sig |
| SECONDARY Percentage of Responders at Month 5 Based on Daily Assessment of NMPP |
38.3; 49.8; 62.1 | 0.005 sig |
| SECONDARY Percentage of Responders at Month 6 Based on Daily Assessment of NMPP |
34.9; 45.7; 62.1 | 0.008 sig |
| SECONDARY Percentage of Responders at Month 1 for DYSP |
26.3; 30.4; 31.8 | 0.306 |
| SECONDARY Percentage of Responders at Month 2 for DYSP |
33.1; 33.7; 44.7 | 0.855 |
| SECONDARY Percentage of Responders at Month 4 for DYSP |
33.1; 44.3; 54.2 | 0.010 sig |
| SECONDARY Percentage of Responders at Month 5 for DYSP |
35.3; 43.7; 54.8 | 0.061 |
| SECONDARY Percentage of Responders at Month 6 for DYSP |
33.3; 39.6; 50.3 | 0.126 |
| SECONDARY Change From Baseline to Month 1 in Mean Pain Score for DYS |
-0.33; -0.83; -0.98 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 2 in Mean Pain Score for DYS |
-0.32; -0.96; -1.68 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 3 in Mean Pain Score for DYS |
-0.35; -1.03; -1.73 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 4 in Mean Pain Score for DYS |
-0.40; -1.05; -1.72 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 5 in Mean Pain Score for DYS |
-0.43; -1.02; -1.84 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Month 1 in Mean Pain Score for DYS |
-14.35; -38.42; -45.35 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Month 2 in Mean Pain Score for DYS |
-13.44; -44.23; -77.22 | -30.79 |
| SECONDARY Percent Change From Baseline to Month 3 in Mean Pain Score for DYS |
-14.80; -47.01; -79.74 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Month 4 in Mean Pain Score for DYS |
-18.08; -48.02; -79.98 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Month 5 in Mean Pain Score for DYS |
-18.09; -46.72; -84.58 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Month 6 in Mean Pain Score for DYS |
-19.21; -40.60; -79.99 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 1 in Mean Pain Score for NMPP |
-0.16; -0.22; -0.26 | 0.111 |
| SECONDARY Change From Baseline to Month 2 in Mean Pain Score for NMPP |
-0.26; -0.33; -0.44 | 0.092 |
| SECONDARY Change From Baseline to Month 3 in Mean Pain Score for NMPP |
-0.32; -0.44; -0.61 | 0.017 sig |
| SECONDARY Change From Baseline to Month 4 in Mean Pain Score for NMPP |
-0.33; -0.51; -0.72 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 5 in Mean Pain Score for NMPP |
-0.34; -0.49; -0.74 | 0.004 sig |
| SECONDARY Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP |
-7.51; -13.74; -15.23 | 0.024 sig |
| SECONDARY Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP |
-13.81; -19.50; -27.53 | 0.078 |
| SECONDARY Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP |
-17.64; -26.10; -40.13 | 0.015 sig |
| SECONDARY Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP |
-17.94; -32.05; -48.35 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP |
-19.60; -31.15; -49.28 | 0.002 sig |
| SECONDARY Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP |
-18.17; -30.55; -48.14 | 0.001 sig |
| SECONDARY Change From Baseline to Month 1 in Mean Pain Score of DYSP |
-0.18; -0.29; -0.22 | 0.038 sig |
| SECONDARY Change From Baseline to Month 2 in Mean Pain Score of DYSP |
-0.26; -0.33; -0.38 | 0.252 |
| SECONDARY Change From Baseline to Month 4 in Mean Pain Score of DYSP |
-0.27; -0.45; -0.61 | 0.009 sig |
| SECONDARY Change From Baseline to Month 5 in Mean Pain Score of DYSP |
-0.30; -0.44; -0.57 | 0.060 |
| SECONDARY Change From Baseline to Month 6 in Mean Pain Score of DYSP |
-0.29; -0.41; -0.60 | 0.118 |
| SECONDARY Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.20; -0.25; -0.32 | 0.313 |
| SECONDARY Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.24; -0.27; -0.46 | 0.519 |
| SECONDARY Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.28; -0.39; -0.57 | 0.037 sig |
| SECONDARY Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.29; -0.36; -0.60 | 0.200 |
| SECONDARY Response to Patient Global Impression of Change (PGIC) at Month 1 |
3.50; 2.97; 2.76 | < 0.001 sig |
| SECONDARY Response to PGIC at Month 2 |
3.13; 2.74; 2.11 | < 0.001 sig |
| SECONDARY Response to PGIC at Month 3 |
3.14; 2.53; 2.01 | < 0.001 sig |
| SECONDARY Response to PGIC at Month 4 |
3.16; 2.54; 1.91 | < 0.001 sig |
| SECONDARY Response to PGIC at Month 5 |
3.19; 2.50; 1.87 | < 0.001 sig |
| SECONDARY Response to PGIC at Month 6 |
3.27; 2.56; 1.92 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 1 in NRS Scores |
-0.72; -1.00; -1.12 | 0.011 sig |
| SECONDARY Change From Baseline to Month 2 in NRS Scores |
-0.91; -1.38; -1.87 | <0.001 sig |
| SECONDARY Change From Baseline to Month 4 in NRS Scores |
-1.15; -1.95; -2.76 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 5 in NRS Scores |
-1.24; -1.92; -2.85 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 6 in NRS Scores |
-1.15; -1.80; -2.75 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) |
-14.47; -20.76; -24.23 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 3 in the Pain Domain of the EHP-30 |
-17.71; -26.99; -36.46 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 6 in the Pain Domain of the EHP-30 |
-15.42; -27.99; -40.52 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 |
-10.47; -11.26; -15.52 | 0.685 |
| SECONDARY Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 |
-12.57; -17.32; -26.44 | 0.047 sig |
| SECONDARY Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 |
-11.56; -16.27; -29.07 | 0.107 |
| SECONDARY Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism |
-1.32; -1.20; -2.49 | 0.741 |
| SECONDARY Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
-1.29; -1.77; -2.56 | 0.172 |
| SECONDARY Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
-0.87; -1.92; -2.65 | 0.016 sig |
| SECONDARY Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
-1.08; -1.85; -2.44 | 0.080 |
| SECONDARY Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
-1.10; -1.75; -2.94 | 0.106 |
| SECONDARY Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism |
-0.27; -1.02; -2.48 | 0.232 |
| SECONDARY Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-1.27; -2.19; -2.89 | 0.013 sig |
| SECONDARY Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-1.43; -2.75; -3.06 | 0.005 sig |
| SECONDARY Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-1.37; -3.00; -3.47 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-1.38; -2.59; -3.61 | 0.004 sig |
| SECONDARY Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-2.13; -3.10; -3.94 | 0.013 sig |
| SECONDARY Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-1.45; -2.73; -3.94 | 0.007 sig |
| SECONDARY Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-4.07; -4.93; -6.00 | 0.326 |
| SECONDARY Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-5.42; -6.83; -8.94 | 0.107 |
| SECONDARY Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-6.23; -7.24; -9.16 | 0.219 |
| SECONDARY Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-6.81; -8.41; -10.70 | 0.026 sig |
| SECONDARY Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-7.80; -8.31; -10.93 | 0.502 |
| SECONDARY Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-6.75; -8.11; -11.21 | 0.108 |
| SECONDARY Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-0.46; -1.64; -1.51 | 0.001 sig |
| SECONDARY Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-1.17; -1.93; -2.23 | 0.045 sig |
| SECONDARY Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-1.35; -1.89; -2.33 | 0.103 |
| SECONDARY Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-1.51; -1.81; -2.55 | 0.390 |
| SECONDARY Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-1.67; -1.86; -2.71 | 0.460 |
| SECONDARY Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-1.48; -2.07; -2.78 | 0.095 |
| SECONDARY Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-5.46; -6.17; -8.69 | 0.462 |
| SECONDARY Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-6.70; -8.72; -11.56 | 0.039 sig |
| SECONDARY Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-7.00; -9.20; -11.90 | 0.032 sig |
| SECONDARY Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-7.84; -10.26; -13.09 | 0.010 sig |
| SECONDARY Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-8.87; -10.04; -14.00 | 0.215 |
| SECONDARY Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-6.88; -9.14; -13.67 | 0.053 |
| SECONDARY Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-1.76; -3.88; -4.36 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-2.60; -4.69; -5.25 | 0.002 sig |
| SECONDARY Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-2.73; -4.90; -5.73 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-2.89; -4.43; -6.13 | 0.017 sig |
| SECONDARY Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-3.80; -4.94; -6.62 | 0.038 sig |
| SECONDARY Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-2.94; -4.78; -6.69 | 0.006 sig |
| SECONDARY Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period |
69; 54; 51; 70; 50; 47 | — |
| SECONDARY Number of Days of Hospitalization |
2.9; 2.0; 2.0 | — |
| SECONDARY Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type |
62; 21; 32; 0; 0; 0 | — |
Summary
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
Eligibility Criteria
Inclusion Criteria
- Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
- Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
- Agrees to use required birth control methods during the entire length of participation in the study.
- Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1
Exclusion Criteria
- Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
- Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
- Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
- Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject has a current history of undiagnosed abnormal genital bleeding.
Data sourced from ClinicalTrials.gov (NCT01620528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.