Phase II Study of CMS-D002 Capsule for Uterine Fibroids 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.

NCT Number	NCT07402369
Lead Sponsor	Shenzhen Kangzhe Biotechnology Co., Ltd.
Conditions	Uterine Fibroids With Menorrhagia
Enrollment	120 participants
Start Date	2026-02-19
Primary Completion	2027-01-03 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-11