# Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

> **NCT03271489** · PHASE3 · COMPLETED · sponsor: **AbbVie** · enrollment: 478 (actual)

## Conditions studied

- Heavy Menstrual Bleeding
- Uterine Fibroids

## Interventions

- **DRUG:** Elagolix
- **DRUG:** Estradiol /norethindrone acetate (E2/NETA)
- **OTHER:** E2/NETA Placebo
- **OTHER:** Elagolix Placebo

## Key facts

- **NCT ID:** NCT03271489
- **Lead sponsor:** AbbVie
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-09-13
- **Primary completion:** 2024-06-28
- **Final completion:** 2024-06-28
- **Target enrollment:** 478 (ACTUAL)
- **Last updated:** 2025-07-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03271489

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03271489, "Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women". Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/clinical/NCT03271489. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*