Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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
Qilu Pharmaceutical Co., Ltd.
120 participants
Jan 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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.
Interventions
* Relugolix (40 mg) tablet administered orally once daily； * megestrol acetate (1 mg) administered orally once daily； * medroxyprogesterone acetate (2 mg) administered orally once daily
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06671548