At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 496 enrolled
Drug / intervention
Elagolixdrug
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.
Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
In Brief
A Phase 3 clinical trial evaluating Elagolix for Endometriosis. Completed, enrolled 496 participants.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartMay 2014
Primary CompletionJun 2016
Study CompletionMay 2017
TodayJul 2026
First PostedMay 21, 2014
Enrollment StartMay 27, 2014
Primary CompletionJun 22, 2016
Study CompletionMay 23, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.1 years ago
Interventions
Elagolixdrug
Elagolix tablets administered orally