Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia

NCT07402369 | Recruiting Phase 2

• 1 other identifier: D002-02-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Fibroids With Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline

  12 weeks

Secondary Outcomes (6)

• 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

  12 weeks

Study Arms (4)

CMS-D002 Capsules 10 mg

EXPERIMENTAL

CMS-D002 Capsules 10 mg, QD

Drug: CMS-D002 Capsules 10 mg

CMS-D002 Capsules 25 mg

EXPERIMENTAL

CMS-D002 Capsules 25 mg, QD

Drug: CMS-D002 Capsules 25 mg

CMS-D002 Capsules 50 mg

EXPERIMENTAL

CMS-D002 Capsules 50 mg, QD

Drug: CMS-D002 Capsules 50 mg

Placebo

PLACEBO COMPARATOR

Placebo, QD

Drug: Placebo

Interventions

CMS-D002 Capsules 10 mg DRUG

CMS-D002 Capsules 10 mg, QD

CMS-D002 Capsules 10 mg

CMS-D002 Capsules 25 mg DRUG

CMS-D002 Capsules 25 mg, QD

CMS-D002 Capsules 25 mg

CMS-D002 Capsules 50 mg DRUG

CMS-D002 Capsules 50 mg, QD

CMS-D002 Capsules 50 mg

Placebo DRUG

Placebo, QD

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shenzhen Kangzhe Biotechnology Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Central Study Contacts

Ying Chen

CONTACT

8615330066563; chenying@cms.net.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 11, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): January 3, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)