Recruiting
Phase 2
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Condition(s) studied
Uterine Fibroids With Menorrhagia
Investigational drug(s) / intervention(s)
CMS-D002 Capsules 10 mgCMS-D002 Capsules 25 mgCMS-D002 Capsules 50 mgPlacebo
CMS-D002 Capsules 10 mg: CMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mg: CMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mg: CMS-D002 Capsules 50 mg, QD
Placebo: Placebo, QD
Study 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 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.
Primary outcome measure(s)
- Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline — 12 weeks
Trial sites (1)
| Facility | City | Region | Status |
| Peking University First Hospital |
Beijing |
Beijing Municipality |
Recruiting |
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