efficacy & safety study of relugolix in women with heavy menstrual bleeding associated with uterine fibroids

Conditions: Heavy Menstrual Bleeding; Uterine Fibroids

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

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.

Eligibility criteria:
inclusion criteria: * 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 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.