CMS-D002 capsules for uterine fibroids with heavy menstrual bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase II study assigns participants to daily CMS-D002 (10, 25, or 50 mg) or matching placebo for 12 weeks to treat menorrhagia related to uterine fibroids. Participants will complete a daily electronic diary to record menstrual bleeding and symptoms, and menstrual blood loss will be measured against a baseline. The primary endpoint is the percentage of participants who achieve menstrual blood loss under 80 mL and a reduction of at least 50% from baseline. Safety and tolerability will also be monitored throughout the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Ying Chen
• Email: chenying@cms.net.cn
• Phone: 8615330066563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.