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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Premenopausal female aged 18 to 50 years old (inclusive)

• Diagnosis of uterine fibroids confirmed by transvaginal ultrasound during the screening period

• Heavy menstrual bleeding caused by uterine fibroids

• Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3

• Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Qi Yu, PhD
yuqimd@163.com
+086-010-69154116
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2027-02
Participants
Target number of participants: 120
Treatments
Experimental: Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group)
Relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg..
Placebo_comparator: Placebo (the placebo group)
Relugolix 40 mg placebo co-administered with megestrol acetate 1 mg placebo and medroxyprogesterone acetate 2 mg placebo for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.
Related Therapeutic Areas
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov