Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase II Clinical Study to Explore the Efficacy and Safety of Different Doses of CMS-D002 Capsule in Participants With Uterine Fibroids Associated With Menorrhagia

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.

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.