# Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

> **NCT01817530** · PHASE2 · COMPLETED · sponsor: **AbbVie** · enrollment: 571 (actual)

## Conditions studied

- Heavy Uterine Bleeding
- Uterine Fibroids

## Interventions

- **OTHER:** Elagolix placebo
- **DRUG:** Elagolix
- **DRUG:** 0.5 mg estradiol / 0.1 mg norethindrone acetate
- **DRUG:** 1 mg estradiol / 0.5 mg norethindrone acetate
- **DRUG:** E2/NETA placebo

## Key facts

- **NCT ID:** NCT01817530
- **Lead sponsor:** AbbVie
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-04-08
- **Primary completion:** 2015-06
- **Final completion:** 2015-12
- **Target enrollment:** 571 (ACTUAL)
- **Last updated:** 2020-07-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01817530

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01817530, "Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01817530. Licensed CC0.

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