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

Recruiting Phase 2 Interventional Study
Uterine Fibroids With Menorrhagia
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 50
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Shenzhen Kangzhe Biotechnology Co., Ltd. · Industry
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About This Trial
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-…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1.Non-menopausal females aged 18-50 years. * 2\. Body Mass Index (BMI) ≥ 18 kg/m². * 3\. Participant was diagnosed with uterine fibroids by ultrasound at the time of screening, and has one or more fibroids with a diameter of at least 2 cm (longest diameter). * 4\. Participant'…
Contacts

Ying Chen

8615330066563

chenying@cms.net.cn

CONTACT