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

Phase

Condition

Sarcoma (Pediatric)

Uterine Fibroids

Menstrual Disorders

Treatment

Relugolix

Relugolix placebo

Clinical Study ID

NCT06671548

QLG1079-301

Ages 18-50
Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

Premenopausal female aged 18 to 50 years old (inclusive)
Diagnosis of uterine fibroids confirmed by transvaginal ultrasound during thescreening period
Heavy menstrual bleeding caused by uterine fibroids
Breast ultrasound results during the screening period meet the BI-RADSclassification of 1 to 3
Able to understand and comply with the study procedures and methods, voluntarilyparticipate in this trial, and sign the informed consent form in writing

Exclusion

Exclusion Criteria:

History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateraloophorectomy, or other surgical procedures during the study period.
Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRHantagonists 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 skincancer, basal cell carcinoma, and other localized malignant tumors.
History of drug abuse, alcohol abuse, or drug dependence within 2 years prior toscreening.
Presence of an in situ copper intrauterine device (IUD) or a progestin-containingIUD implant/subdermal contraceptive implant during the screening period; subjectswho can remove the IUD/subdermal contraceptive implant at least 1 month beforeenrollment may be allowed to participate.
Baseline bone mineral density Z-score of < -2.0 at the lumbar spine, total hip, orfemoral neck during the screening period.
Any other factors that the investigator deems unsuitable for participation in thistrial.

Study Design

Relugolix

February 28, 2025

February 28, 2027

Study 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.

Connect with a study center

Peking Union Medical College Hospital
Beijing,
China
Active - Recruiting

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