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

NCT07402369 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Kangzhe Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-19
Primary Completion
2027-01-03
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07402369 on ClinicalTrials.gov