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

NCT ID: NCT06671548

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-01-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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..

Group Type: EXPERIMENTAL

Relugolix

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Relugolix placebo

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

megestrol acetate; medroxyprogesterone acetate; megestrol acetate placebo; medroxyprogesterone acetate placebo

Eligibility Criteria

Inclusion Criteria

• Premenopausal female aged 18 or older
• Diagnosis of uterine fibroids confirmed by transvaginal/rectal 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

Exclusion Criteria

• History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period.
• Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed.
• History of or current osteoporosis or other metabolic bone disease.
• History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors.
• History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening.
• Presence of an in situ copper intrauterine device (IUD) or a progestin-containing IUD implant/subdermal contraceptive implant during the screening period; subjects who can remove the IUD/subdermal contraceptive implant at least 1 month before enrollment may be allowed to participate.
• Baseline bone mineral density Z-score of < -2.0 at the lumbar spine, total hip, or femoral neck during the screening period.
• Any other factors that the investigator deems unsuitable for participation in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qi Yu, PhD

Role: CONTACT

yuqimd@163.com

+086-010-69154116

Facility Contacts

Yu Qi

Role: primary

Other Identifiers

QLG1079-301

Identifier Type: -

Identifier Source: org_study_id