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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •5. Menorrhagia due to uterine fibroids.
- •6. Agrees to use the contraceptive method specified in the protocol throughout the entire study period (from signing the informed consent form to 6 months after administration of the investigational drug).
排除标准
- •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)
- •5. Underwent myomectomy, endometrial ablation, uterine artery embolization, or magnetic resonance-guided focused ultrasound (MRgFUS)/high-intensity focused ultrasound (HIFUS) ablation within 6 months prior to screening
- •6. Underwent endometrial ablation within one year prior to screening
- •7. Severe infection, severe trauma, or major surgery within the 6 months prior to screening.
- •8. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors).
- •9. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse).
- •10. Currently participating in other research projects and having used the investigational drug/treatment within 12 weeks prior to administration.
研究组 & 干预措施
CMS-D002 Capsules 25 mg
CMS-D002 Capsules 25 mg, QD
干预措施: CMS-D002 Capsules 25 mg (Drug)
CMS-D002 Capsules 10 mg
CMS-D002 Capsules 10 mg, QD
干预措施: CMS-D002 Capsules 10 mg (Drug)
Placebo
Placebo, QD
干预措施: Placebo (Drug)
CMS-D002 Capsules 50 mg
CMS-D002 Capsules 50 mg, QD
干预措施: CMS-D002 Capsules 50 mg (Drug)
结局指标
主要结局
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
时间窗: 12 weeks
次要结局
- Changes in maximum fibroid volume from baseline(12weeks)
- Changes in uterine volume from baseline(12weeks)
- Percentage of participants without menstrual bleeding or spotting(4、8、12 weeks)
- Changes in hemoglobin concentration from baseline(4、8、12 weeks)
- Changes in uterine fibroid symptoms and quality of life questionnaire (UFS-QoL) scores from baseline(12 weeks)
- Adverse events(Up to week 18)