At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 413 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 413 participants across 96 sites in 3 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, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedJan 2016
Primary CompletionJan 2018
Study CompletionDec 2018
TodayJul 2026
First PostedJan 13, 2016
Enrollment StartDec 22, 2015
Primary CompletionJan 18, 2018
Study CompletionDec 12, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.5 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