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.
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's menstrual cycle was ≥ 21 days and ≤ 35 days for the three consecutive months prior to screening, and the menstrual period was ≤ 14 days.
1. Pregnant or breastfeeding female
2. History of childbirth within 6 months prior to screening
3. Excessive menstrual bleeding due to other causes or unknown reasons
4. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease)
Parallel
CMS-D002 Capsules 10 mg
DrugCMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mg
DrugCMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mg
DrugCMS-D002 Capsules 50 mg, QD
Placebo
DrugPlacebo, QD
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
Changes in maximum fibroid volume from baseline
Changes in uterine volume from baseline
Percentage of participants without menstrual bleeding or spotting
Changes in hemoglobin concentration from baseline
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