Actively Recruiting
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Led by Shenzhen Kangzhe Biotechnology Co., Ltd. · Updated on 2026-03-11
120
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objective This study evaluates whether CMS-D002 capsules are effective in treating menorrhagia in participants with uterine fibroids associated with menorrhagia. The primary outcome is the percentage of participants who achieve menstrual blood loss \<80 mL and a reduction of ≥50% from baseline. Study Design This is a placebo-controlled trial. Participants will be randomized to receive either CMS-D002 capsules or a matching placebo for 12 weeks. Participant Responsibilities Take one CMS-D002 capsule or placebo daily for 12 weeks. Complete an electronic patient diary daily throughout the study to record menstrual bleeding and other symptoms.
CONDITIONS
Official Title
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-menopausal females aged 18 to 50 years
- Body Mass Index (BMI) of 18 kg/m² or higher
- Diagnosed with uterine fibroids by ultrasound with at least one fibroid measuring 2 cm or more in diameter
- Menstrual cycle length between 21 and 35 days for three consecutive months prior to screening, with menstrual periods lasting 14 days or less
- Menorrhagia due to uterine fibroids
- Agrees to use specified contraceptive methods throughout the study and for 6 months after treatment
You will not qualify if you...
- Pregnant or breastfeeding females
- History of childbirth within 6 months before screening
- Excessive menstrual bleeding caused by other reasons or unknown causes
- Severe coagulation disorders such as hemophilia or von Willebrand disease
- Had myomectomy, endometrial ablation, uterine artery embolization, or MRgFUS/HIFUS ablation within 6 months before screening
- Underwent endometrial ablation within one year before screening
- Severe infection, trauma, or major surgery within 6 months before screening
- History of malignant tumors within 5 years before screening (except cured skin cancers and localized tumors)
- Current or past (within 1 year) alcohol or drug abuse, including analgesic abuse
- Participation in other research or use of investigational drugs within 12 weeks before treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Y
Ying Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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