CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 478 enrolled
Drug / intervention
Elagolix +3 moredrug
Likely dose
Elagolix 300 mgfrom 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.

Search/NCT03271489
NCT03271489Phase 3Completed
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A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

AbbVie·interventional·Posted Sep 5, 2017·Updated Jul 22, 2025

In Brief

A Phase 3 clinical trial evaluating Elagolix, Estradiol /norethindrone acetate (E2/NETA), and 2 other interventions for Heavy Menstrual Bleeding and Uterine Fibroids. Completed, enrolled 478 participants across 157 sites in 2 countries.

Detailed Summary

This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeavy Menstrual Bleeding, Uterine Fibroids
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 5, 2017
Enrollment StartSep 13, 2017
Primary CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 8.8 years ago

Interventions

Elagolixdrug

Film-coated 300 mg tablets

Estradiol /norethindrone acetate (E2/NETA)drug

Estradiol 1 mg/norethindrone acetate 0.5 mg capsules

E2/NETA Placeboother

Placebo capsules

Elagolix Placeboother

Film-coated placebo tablets