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
Shenzhen Kangzhe Biotechnology Co., Ltd.
120 participants
Feb 19, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Non-menopausal females aged 18-50 years.
- \. Body Mass Index (BMI) ≥ 18 kg/m².
- \. 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).
- \. 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.
- \. Menorrhagia due to uterine fibroids.
- \. 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 Criteria10
- \. Pregnant or breastfeeding female
- \. History of childbirth within 6 months prior to screening
- \. Excessive menstrual bleeding due to other causes or unknown reasons
- \. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease)
- \. 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
- \. Underwent endometrial ablation within one year prior to screening
- \. Severe infection, severe trauma, or major surgery within the 6 months prior to screening.
- \. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors).
- \. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse).
- \. Currently participating in other research projects and having used the investigational drug/treatment within 12 weeks prior to administration.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
CMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mg, QD
Placebo, QD
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07402369