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RECRUITING
NCT06671548
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-01-15

Completion Date

2027-01-07

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Relugolix

* Relugolix (40 mg) tablet administered orally once daily; * megestrol acetate (1 mg) administered orally once daily; * medroxyprogesterone acetate (2 mg) administered orally once daily

DRUG

Relugolix placebo

Relugolix (0 mg) tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. megestrol acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. medroxyprogesterone acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Locations (1)

Peking Union Medical College Hospital

Beijing, China