# A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

> **NCT02655237** · PHASE3 · COMPLETED · sponsor: **Takeda** · enrollment: 281 (actual)

## Conditions studied

- Uterine Fibroids

## Interventions

- **DRUG:** Relugolix
- **DRUG:** Relugolix Placebo
- **DRUG:** Leuprorelin
- **DRUG:** Leuprorelin Placebo

## Key facts

- **NCT ID:** NCT02655237
- **Lead sponsor:** Takeda
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2016-03-05
- **Primary completion:** 2017-05-17
- **Final completion:** 2017-09-25
- **Target enrollment:** 281 (ACTUAL)
- **Last updated:** 2019-03-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02655237

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02655237, "A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT02655237. Licensed CC0.

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