Phase 3
N=495
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT02143713 ↗Enrolled (actual)
495
Serious AEs
5.5%
Results posted
Sep 2018
Primary outcome: Primary: Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment — 37.0; 57.1; 50.8; 75.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Elagolix (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AbbVie
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment |
37.0; 57.1; 50.8; 75.9 | — |
| PRIMARY Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment |
27.2; 32.7; 66.4; 67.2 | — |
| SECONDARY Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment |
11.8; 24.5; 56.7; 74.3; 36.5; 62.3 | — |
| SECONDARY Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment |
12.7; 18.2; 61.7; 62.1; 20.8; 27.4 | — |
| SECONDARY Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment |
23.1; 27.3; 50.5; 63.4; 30.6; 35.1 | — |
| SECONDARY Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment |
-18.4; -27.0; -54.6; -81.3; -47.6; -70.2 | — |
| SECONDARY Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment |
-7.3; -11.3; -47.9; -54.0; -7.8; -12.8 | — |
| SECONDARY Percent Change From Baseline in Dyspareunia Based on Daily Assessment |
-10.4; -16.9; -43.7; -48.7; -12.0; -19.2 | — |
| SECONDARY Change From Baseline in Any Rescue Analgesic Use |
-0.07; -0.16; -0.44; -0.47; -0.16; -0.24 | — |
| SECONDARY Change From Baseline in NSAID Rescue Analgesic Use |
-0.05; -0.12; -0.25; -0.28; -0.10; -0.18 | — |
| SECONDARY Change From Baseline in Opioid Rescue Analgesic Use |
-0.02; -0.04; -0.19; -0.20; -0.06; -0.06 | — |
| SECONDARY Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) |
-12.0; -18.2; -50.8; -58.7; -20.7; -25.8 | — |
| SECONDARY Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved |
50.0; 56.8; 65.7; 78.3; 58.7; 74.5 | — |
| SECONDARY Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension |
-8.02; -12.18; -32.25; -36.45; -11.12; -15.25 | — |
| SECONDARY Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension |
-3.29; -10.35; -24.17; -28.37; -9.26; -12.50 | — |
| SECONDARY Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household |
-2.82; -1.33; -1.25; -1.73; -10.31; -8.37 | — |
| SECONDARY Number of Participants With Non-study Health Visits During the Treatment Period |
48; 65; 76; 76 | — |
| SECONDARY Number of Days in Hospital During the Treatment Period |
2.0; 4.0; 3.0; 3.0 | — |
Summary
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal Study M12-671 (NCT01931670).
Eligibility Criteria
Inclusion Criteria
- Subject has completed the 6-Month Treatment Period in pivotal study M12-671.
- Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period
Exclusion Criteria
- Clinically significant gynecological condition
- Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
- Plans to become pregnant in the next 18 months
Data sourced from ClinicalTrials.gov (NCT02143713). 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.