# 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 (Replicate Study)

> **NCT02691494** · PHASE3 · COMPLETED · sponsor: **AbbVie** · enrollment: 378 (actual)

## Conditions studied

- Uterine Fibroids
- Heavy Menstrual Bleeding

## Interventions

- **DRUG:** Elagolix
- **DRUG:** Placebo for Estradiol/Norethindrone Acetate
- **DRUG:** Estradiol/Norethindrone Acetate
- **DRUG:** Placebo for Elagolix

## Key facts

- **NCT ID:** NCT02691494
- **Lead sponsor:** AbbVie
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2016-02-03
- **Primary completion:** 2018-02-14
- **Final completion:** 2019-01-23
- **Target enrollment:** 378 (ACTUAL)
- **Last updated:** 2021-07-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02691494

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02691494, "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 (Replicate Study)". Retrieved via MORVS 2026-10-19 from https://api.morvs.ai/clinical/NCT02691494. Licensed CC0.

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