Phase 3
Completed N=504
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
Source: ClinicalTrials.gov NCT01760954 ↗Enrolled (actual)
504
Serious AEs
3.8%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment — 52.1; 78.2; 32.6; 64.4 percentage of participants
◆ Published Evidence
Established
31citations · ~4 / year
Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis.
Summary
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.
Linked Publications (5)
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Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis.
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Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain.
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Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.
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Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis.
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Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment |
52.1; 78.2; 32.6; 64.4 | — |
| PRIMARY Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment |
67.5; 69.1; 39.5; 57.5 | — |
| SECONDARY Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment |
48.0; 80.9; 21.0; 20.6; 51.1; 78.9 | — |
| SECONDARY Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment |
55.4; 74.3; 23.8; 29.0; 62.6; 69.5 | — |
| SECONDARY Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment |
50.0; 61.3; 33.3; 15.6; 51.9; 58.3 | — |
| SECONDARY Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment |
-46.7; -82.7; -19.0; -19.3; -46.7; -84.8 | — |
| SECONDARY Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment |
-37.4; -54.5; -9.6; -20.7; -41.4; -56.4 | — |
| SECONDARY Percent Change From Baseline in Dyspareunia Based on Daily Assessment |
-32.8; -39.5; -12.9; -1.1; -36.2; -40.4 | — |
| SECONDARY Change From Baseline in Any Rescue Analgesic Use |
-0.35; -0.58; -0.15; -0.16; -0.35; -0.59 | — |
| SECONDARY Change From Baseline in NSAID Rescue Analgesic Use |
-0.24; -0.34; -0.07; -0.09; -0.24; -0.34 | — |
| SECONDARY Change From Baseline in Opioid Rescue Analgesic Use |
-0.11; -0.24; -0.09; -0.07; -0.11; -0.25 | — |
| SECONDARY Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) |
-41.0; -60.0; -9.2; -22.3; -44.4; -62.1 | — |
| SECONDARY Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved |
63.3; 86.4; 47.1; 45.5; 64.7; 87.3 | — |
| SECONDARY Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension |
-29.50; -40.28; -12.98; -13.27; -30.10; -43.16 | — |
| SECONDARY Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension |
-19.81; -29.42; -8.15; -9.86; -20.88; -27.27 | — |
| SECONDARY Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household |
-1.84; -3.01; -2.15; -2.78; -11.14; -12.45 | — |
| SECONDARY Number of Participants With Non-study Health Visits During the Treatment Period |
81; 68; 59; 48 | — |
| SECONDARY Number of Days in Hospital During the Treatment Period |
2.0; 1.5; 3.0; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)
- 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 (NCT01760954) and the linked publication. 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. Informational only — not medical advice.