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RECRUITING
NCT07402369
PHASE2

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

Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China