Actively Recruiting
Phase 3 Study of Relugolix Tablets for Heavy Menstrual Bleeding Associated With Uterine Fibroids in Women
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-02-02
120
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating relugolix combined with megestrol acetate and medroxyprogesterone acetate for women experiencing heavy menstrual bleeding linked to uterine fibroids. This phase 3 trial aims to assess the benefits and safety of taking relugolix 40 mg daily compared to a placebo. About 120 women will participate, helping to answer how well this treatment reduces menstrual bleeding and its safety profile. Participants will be randomly assigned in a 2:1 ratio to receive either daily oral relugolix 40 mg together with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks or placebo tablets matching these drugs for 12 weeks. After this double-blind period, all participants will receive the active treatment combination for another 12 weeks. The study includes a screening period lasting up to approximately 13 weeks and a 4-week follow-up period. Throughout the study, women will undergo safety checks including monitoring for adverse events, vital signs, physical exams, lab tests, bone density assessments, and heart function tests. Researchers will measure how many participants achieve a significant reduction in menstrual blood loss by the end of the double-blind period. Participants will be involved in clinic visits and assessments across the study duration, which includes screening, treatment, and follow-up phases.
CONDITIONS
Brief 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 results classified as BI-RADS 1 to 3 during screening
- Able to understand and comply with study procedures and provide written informed consent
You will not qualify if you...
- History of bilateral oophorectomy or planned hysterectomy, bilateral oophorectomy, or other surgeries during the study
- Previous unsuccessful treatment with gonadotropin-releasing hormone (GnRH) agonists or antagonists for uterine fibroids
- History of or current osteoporosis or metabolic bone disease
- History of malignant tumor within 5 years before screening, except cured skin cancer or localized malignant tumors
- History of drug or alcohol abuse within 2 years before screening
- Presence of copper intrauterine device (IUD) or progestin-containing IUD or contraceptive implant during screening unless removed at least 1 month before enrollment
- Baseline bone mineral density Z-score below -2.0 at lumbar spine, total hip, or femoral neck
- Any other factors considered unsuitable by the investigator for participation
AI-Screening
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Your Study Journey
Duration - Up to ~13 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive daily oral medication with relugolix combined with megestrol acetate and medroxyprogesterone acetate or placebo for 12 weeks in a double-blind manner.
Visits scheduled during the 12-week double-blind treatment period
Duration - 12 weeks
Participants receive daily oral relugolix combined with megestrol acetate and medroxyprogesterone acetate for an additional 12 weeks in an open-label manner.
Visits scheduled during the 12-week open-label treatment period
Duration - 4 weeks
Participants are monitored for safety and adverse events after completing treatment.
Visits during the 4-week follow-up period
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Q
Qi Yu, PhD
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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