Phase 3
N=815
A Global Phase 3 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: NCT01931670 ↗Enrolled (actual)
815
Serious AEs
3.6%
Results posted
Sep 2018
Primary outcome: Primary: Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) — 22.7; 43.4; 72.4 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Other); Elagolix (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AbbVie
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) |
22.7; 43.4; 72.4 | < 0.001 sig |
| PRIMARY Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) |
36.5; 49.8; 57.8 | 0.003 sig |
| SECONDARY Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores |
-1.33; -1.90; -2.55 | <0.001 sig |
| SECONDARY Change From Baseline to Month 6 in DYS |
-0.52; -1.06; -1.65 | < 0.001 sig |
| SECONDARY Change From Baseline to Month 6 in NMPP |
-0.48; -0.63; -0.80 | 0.009 sig |
| SECONDARY Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.31; -0.36; -0.49 | 0.26 |
| SECONDARY Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.32; -0.40; -0.52 | 0.088 |
| SECONDARY Change From Baseline to Month 3 in Dyspareunia (DYSP) |
-0.30; -0.39; -0.60 | 0.172 |
| SECONDARY Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) |
-0.12; -0.12; -0.21 | 0.968 |
| SECONDARY Percentage of Responders for Each Month, Except Month 3, in DYS |
17.3; 33.0; 46.2; 19.0; 39.4; 69.8 | < 0.001 sig |
| SECONDARY Percentage of Responders for Each Month, Except Month 3, in NMPP |
23.5; 27.6; 29.3; 32.1; 39.8; 50.7 | 0.376 |
| SECONDARY Percentage of Responders at Each Month for DYSP |
33.3; 33.8; 35.1; 33.2; 39.9; 47.4 | 0.901 |
| SECONDARY Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS |
-0.33; -0.86; -1.11; -0.39; -0.84; -1.67 | < 0.001 sig |
| SECONDARY Percent Change From Baseline to Each Month in Mean Pain Score for DYS |
-14.36; -39.67; -53.68; -17.36; -39.26; -80.68 | < 0.001 sig |
| SECONDARY Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP |
-0.22; -0.24; -0.31; -0.34; -0.41; -0.54 | 0.549 |
| SECONDARY Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP |
-12.43; -15.47; -18.86; -21.13; -26.30; -34.32 | 0.301 |
| SECONDARY Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP |
-0.21; -0.19; -0.26; -0.25; -0.32; -0.49 | 0.688 |
| SECONDARY Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics |
-0.20; -0.29; -0.32; -0.25; -0.32; -0.44 | 0.029 sig |
| SECONDARY Patient Global Impression of Change (PGIC) Questionnaire |
3.49; 3.12; 2.84; 3.24; 2.62; 2.15 | < 0.001 sig |
| SECONDARY Change From Baseline to Each Month, Except Month 3, in NRS Scores |
-0.78; -1.06; -1.23; -1.08; -1.62; -2.04 | 0.02 sig |
| SECONDARY Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores |
-15.20; -19.40; -22.75; -19.29; -26.62; -34.72 | 0.007 sig |
| SECONDARY Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores |
-9.89; -10.46; -14.29; -14.51; -17.26; -25.20 | 0.77 |
| SECONDARY Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism |
-0.61; -1.62; -1.56; -0.82; -1.80; -2.25 | 0.019 sig |
| SECONDARY Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism |
-1.45; -2.08; -2.30; -1.63; -2.75; -3.06 | 0.131 |
| SECONDARY Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism |
-1.60; -2.94; -4.69; -3.43; -4.74; -7.08 | 0.186 |
| SECONDARY Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism |
-0.71; -0.69; -0.72; -1.06; -1.28; -1.46 | 0.975 |
| SECONDARY Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace |
-2.19; -4.02; -5.91; -4.25; -6.27; -9.36 | 0.098 |
| SECONDARY Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household |
-2.18; -2.78; -2.89; -2.71; -4.04; -4.48 | 0.335 |
| SECONDARY Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period |
99; 53; 57; 93; 47; 54 | — |
| SECONDARY Number of Days of Hospitalization |
3.2; 3.3; 2.2 | — |
| SECONDARY Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type |
37; 28; 22; 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 subjects.
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 the Washout Period.
- 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 or greater at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
- 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
- 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 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 uterine bleeding.
Data sourced from ClinicalTrials.gov (NCT01931670). 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.