CMS-D002 capsules for uterine fibroids with heavy menstrual bleeding

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

This test will see if taking a daily CMS-D002 capsule for 12 weeks reduces heavy menstrual bleeding in women aged 18–50 with uterine fibroids.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07402369 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Non-menopausal women aged 18–50 with ultrasound-confirmed uterine fibroids (at least one fibroid ≥2 cm), documented menorrhagia, regular cycles per protocol, and agreement to required contraception are ideal candidates.

Not a fit: Women who are pregnant or breastfeeding, recently gave birth, have heavy bleeding from other causes, or have severe coagulation disorders are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, CMS-D002 could reduce menstrual blood loss and related symptoms, potentially lowering the need for surgical procedures or transfusions.

How similar studies have performed: Other oral treatments for fibroid-related heavy bleeding have demonstrated benefit, but CMS-D002 is a novel agent and this Phase II trial is needed to confirm its effects.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ying Chen

Conditions: Uterine Fibroids With Menorrhagia