Clinical Trial

Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Recruiting Phase 3
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Summary
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question\[s\] it aims to answer are: * the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids * the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-01; most recent amendment 2026-01-29.
Status change: Not Yet Recruiting → Recruiting 2025-07-29
Trial Details
NCT Number NCT06671548
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Heavy Menstrual Bleeding, Uterine Fibroids
Enrollment 120 participants
Start Date 2024-01-15
Primary Completion 2026-11-12 (estimated)
Study Completion 2027-01-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-02