At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 433 enrolled
Drug / intervention
Estradiol/Norethindrone Acetate +1 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.
Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating Estradiol/Norethindrone Acetate and Elagolix for Uterine Fibroids and Heavy Menstrual Bleeding. Completed, enrolled 433 participants across 124 sites in 3 countries.
Detailed Summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids, Heavy Menstrual Bleeding
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedOct 2016
Primary CompletionMay 2018
Study CompletionMar 2019
TodayJul 2026
First PostedOct 6, 2016
Enrollment StartSep 14, 2016
Primary CompletionMay 7, 2018
Study CompletionMar 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.7 years ago
Interventions
Estradiol/Norethindrone Acetatedrug
capsules
Elagolixdrug
film-coated tablets