At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 571 enrolled
Drug / intervention
Elagolix +4 moredrug
Likely dose
0.5 mg estradiol / 0.1 mg norethindrone acetatefrom 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 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
In Brief
A Phase 2 clinical trial evaluating Elagolix placebo, Elagolix, and 3 other interventions for Heavy Uterine Bleeding and Uterine Fibroids. Completed, enrolled 571 participants.
Detailed Summary
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeavy Uterine Bleeding, Uterine Fibroids
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartApr 2013
Primary CompletionJun 2015
Study CompletionDec 2015
TodayJul 2026
First PostedMar 25, 2013
Enrollment StartApr 8, 2013
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.3 years ago
Interventions
Elagolix placeboother
oral coated tablet
Elagolixdrug
oral coated tablet
0.5 mg estradiol / 0.1 mg norethindrone acetatedrug
oral hard capsule
1 mg estradiol / 0.5 mg norethindrone acetatedrug
oral hard capsule
E2/NETA placebodrug
oral hard capsule