NCT07402369

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	CMS-D002 Capsules 10 mg	CMS-D002 Capsules 10 mg, QD
DRUG	CMS-D002 Capsules 25 mg	CMS-D002 Capsules 25 mg, QD
DRUG	CMS-D002 Capsules 50 mg	CMS-D002 Capsules 50 mg, QD
DRUG	Placebo	Placebo, QD

Timeline

• Start date: 2026-02-19
• Primary completion: 2027-01-03
• Completion: 2027-12-31
• First posted: 2026-02-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: China