NCT06671548

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-designed efficacy and safety study to evaluate 12 weeks of oral daily relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg (the treatment group) or 12 weeks of daily oral relugolix 40 mg placebo (the placebo group) followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg. Approximately 120 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled and randomized 2:1 to the treatment group (N=80) or placebo group (N=40). Stratification variables will include mean screening menstrual blood loss volume (\< 225 mL versus ≥ 225 mL) by the alkaline hematin method. The study consists of a screening period (up to \~13 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (12 weeks) and a follow-up period (4w). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.

Conditions

• Heavy Menstrual Bleeding
• Uterine Fibroids

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-11-12
• Completion: 2027-01-07
• First posted: 2024-11-04
• Last updated: 2026-02-02

Locations

1 site across 1 country: China