RecruitingPhase 3NCT06671548

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

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

120 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Heavy Menstrual Bleeding Uterine Fibroids

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the drug relugolix (a hormone-blocking pill) to see whether it safely and effectively reduces heavy menstrual bleeding caused by uterine fibroids (noncancerous growths in the uterus). **You may be eligible if...** - You are a premenopausal woman aged 18 or older - You have been diagnosed with uterine fibroids confirmed by ultrasound - You experience heavy menstrual bleeding due to fibroids - Your breast ultrasound results are in a normal-to-benign range (BI-RADS 1–3) **You may NOT be eligible if...** - You have had both ovaries removed, or you plan to have a hysterectomy or ovary removal during the study - You previously tried and failed treatment with GnRH drugs (hormone-suppressing medications used for fibroids) - You have osteoporosis or a history of bone fractures related to low bone density - You have certain other health conditions that the study doctor considers risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelugolix

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

DRUGRelugolix 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.