At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 378 enrolled
Drug / intervention
Elagolix +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 Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
In Brief
A Phase 3 clinical trial evaluating Elagolix, Placebo for Estradiol/Norethindrone Acetate, and 2 other interventions for Uterine Fibroids and Heavy Menstrual Bleeding. Completed, enrolled 378 participants across 105 sites in 2 countries.
Detailed Summary
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids, Heavy Menstrual Bleeding
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedFeb 2016
Primary CompletionFeb 2018
Study CompletionJan 2019
TodayJul 2026
First PostedFeb 25, 2016
Enrollment StartFeb 3, 2016
Primary CompletionFeb 14, 2018
Study CompletionJan 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.4 years ago
Interventions
Elagolixdrug
Film-coated tablets
Placebo for Estradiol/Norethindrone Acetatedrug
Placebo capsules
Estradiol/Norethindrone Acetatedrug
Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
Placebo for Elagolixdrug
Film-coated placebo tablets