Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Uterine Fibroids With Menorrhagia
In brief
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.
Key facts
- Study ID
- NCT07402369
- Run by
- Shenzhen Kangzhe Biotechnology Co., Ltd.
- People needed
- 120
- Starts
- 2026-02-19
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 1.Non-menopausal females aged 18-50 years.
- 2. Body Mass Index (BMI) ≥ 18 kg/m².
- 3. Participant was diagnosed with uterine fibroids by ultrasound at the time of screening, and has one or more fibroids with a diameter of at least 2 cm (longest diameter).
- 4. Participant's menstrual cycle was ≥ 21 days and ≤ 35 days for the three consecutive months prior to screening, and the menstrual period was ≤ 14 days.
- 5. Menorrhagia due to uterine fibroids.
- 6. Agrees to use the contraceptive method specified in the protocol throughout the entire study period (from signing the informed consent form to 6 months after administration of the investigational drug).
You may not qualify if…
- 1. Pregnant or breastfeeding female
- 2. History of childbirth within 6 months prior to screening
- 3. Excessive menstrual bleeding due to other causes or unknown reasons
- 4. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease)
- 5. Underwent myomectomy, endometrial ablation, uterine artery embolization, or magnetic resonance-guided focused ultrasound (MRgFUS)/high-intensity focused ultrasound (HIFUS) ablation within 6 months prior to screening
- 6. Underwent endometrial ablation within one year prior to screening
- 7. Severe infection, severe trauma, or major surgery within the 6 months prior to screening.
- 8. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors).
- 9. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse).
- 10. Currently participating in other research projects and having used the investigational drug/treatment within 12 weeks prior to administration.
Where it is running
- Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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