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

NCT06671548 | Recruiting Phase 3

• 1 other identifier: QLG1079-301
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Heavy Menstrual Bleeding; Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume

  A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of the double-blind treatment period. All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 12/early termination feminine product collection interval (up to 35 days prior to the last dose of double-blind treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg with placebo. Therefore, only relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg and placebo arms are presented.

  From Baseline up to the last 35 days of the double-blind treatment period

Secondary Outcomes (1)

• Percentage Of Participants With Amenorrhea Over The Last 35 Days Of the double-blind treatment period

  From Baseline up to the last 35 days of the double-blind treatment period

Study Arms (2)

Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group)

EXPERIMENTAL

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..

Drug: Relugolix

Placebo (the placebo group)

PLACEBO COMPARATOR

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.

Drug: Relugolix placebo

Interventions

Relugolix 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

Also known as: megestrol acetate, medroxyprogesterone acetate

Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group)

Relugolix placebo 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.

Also known as: megestrol acetate placebo, medroxyprogesterone acetate placebo

Placebo (the placebo group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Menorrhagia; Leiomyoma

Interventions

relugolix; Megestrol Acetate; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes

Central Study Contacts

Qi Yu, PhD

CONTACT

+086-010-69154116; yuqimd@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): January 7, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)