drugset / Trial / NCT06671548

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

NCT06671548

Phase 3 Recruiting 120 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2024-01-15
Primary completion
2026-11-12
Completion
2027-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Relugolix Small molecule 40 mg Oral
Background Megestrol Acetate Other / unclassified 1 mg Oral
Background medroxyprogesterone acetate Other / unclassified 2 mg Oral

Indications