Actively Recruiting
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-02-02
120
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal female aged 18 or older
- Diagnosis of uterine fibroids confirmed by transvaginal or rectal ultrasound during screening
- Heavy menstrual bleeding caused by uterine fibroids
- Breast ultrasound during screening meets BI-RADS classification 1 to 3
- Able to understand, comply with study procedures, voluntarily participate, and sign informed consent
You will not qualify if you...
- History of bilateral oophorectomy or planned hysterectomy, bilateral oophorectomy, or other surgery during study
- Previous failed treatment with gonadotropin-releasing hormone (GnRH) agonists or antagonists for uterine fibroids
- History or current osteoporosis or other metabolic bone disease
- History of malignant tumor within 5 years prior to screening, except cured skin cancer or localized malignancies
- History of drug or alcohol abuse or dependence within 2 years prior to screening
- Presence of in situ copper IUD or progestin-containing IUD/contraceptive implant during screening (must be removed at least 1 month before enrollment)
- Baseline bone mineral density Z-score less than -2.0 at lumbar spine, total hip, or femoral neck during screening
- Any other factors deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Q
Qi Yu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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