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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Fibroids With Menorrhagia
• Intervention / Treatment: Drug: Placebo; Drug: CMS-D002 Capsules 10 mg; Drug: CMS-D002 Capsules 25 mg; Drug: CMS-D002 Capsules 50 mg

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ying Chen; Phone Number: 8615330066563; Email: chenying@cms.net.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Yingfang Zhou; Phone Number: 861083573316; Email: pc54014@163.com
      • Contact: Chao Peng; Phone Number: 861083573316

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo, QD	Drug: Placebo; Placebo, QD
Experimental: CMS-D002 Capsules 10 mg; CMS-D002 Capsules 10 mg, QD	Drug: CMS-D002 Capsules 10 mg; CMS-D002 Capsules 10 mg, QD
Experimental: CMS-D002 Capsules 25 mg; CMS-D002 Capsules 25 mg, QD	Drug: CMS-D002 Capsules 25 mg; CMS-D002 Capsules 25 mg, QD
Experimental: CMS-D002 Capsules 50 mg; CMS-D002 Capsules 50 mg, QD	Drug: CMS-D002 Capsules 50 mg; CMS-D002 Capsules 50 mg, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in maximum fibroid volume from baseline		12weeks
Changes in uterine volume from baseline		12weeks
Percentage of participants without menstrual bleeding or spotting		4、8、12 weeks
Changes in hemoglobin concentration from baseline		4、8、12 weeks
Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline	Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.	12 weeks
Adverse events		Up to week 18

Collaborators and Investigators

• Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2026
• Primary Completion (Estimated): January 3, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D002-02-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect the privacy and confidentiality of study participants, in accordance with ethical guidelines and regulatory requirements, individual participant data (IPD) will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No