At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 681 enrolled
Drug / intervention
Estradiol/Norethindrone Acetate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain
In Brief
A Phase 3 clinical trial evaluating Estradiol/Norethindrone Acetate, Placebo for Elagolix, and 2 other interventions for Endometriosis. Completed, enrolled 681 participants across 197 sites in 3 countries.
Detailed Summary
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJul 2017
First PostedJul 2017
Primary CompletionMar 2020
Study CompletionDec 2023
TodayJul 2026
First PostedJul 11, 2017
Enrollment StartJul 7, 2017
Primary CompletionMar 27, 2020
Study CompletionDec 6, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.0 years ago
Interventions
Estradiol/Norethindrone Acetatedrug
Tablets
Placebo for Elagolixdrug
Tablet
Elagolixdrug
Tablet
Placebo for E2/NETAdrug
Tablets