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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
CMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mg, QD
Placebo, QD
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Time frame: 12 weeks
Changes in maximum fibroid volume from baseline
Time frame: 12weeks
Changes in uterine volume from baseline
Time frame: 12weeks
Percentage of participants without menstrual bleeding or spotting
Time frame: 4、8、12 weeks
Changes in hemoglobin concentration from baseline
Time frame: 4、8、12 weeks
Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline
Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.
Time frame: 12 weeks
Adverse events
Time frame: Up to week 18
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