Clinical trial NCT06671548: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Heavy Menstrual Bleeding
Uterine Fibroids
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume
timeFrame: From Baseline up to the last 35 days of the double-blind treatment period
Secondary outcomes:
measure: Percentage Of Participants With Amenorrhea Over The Last 35 Days Of the double-blind treatment period
timeFrame: From Baseline up to the last 35 days of the double-blind treatment period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: