Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase II Study of CMS-D002 Capsule for Uterine Fibroids With Menorrhagia
Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-02-19
Completion Date
2027-12-31
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China