jRCT2011240049招募中不适用
Phase 2/3 study of MD-352 in patients with dysmenorrhoea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 285
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Patients diagnosed with primary dysmenorrhea or secondary dysmenorrhea.
- •Patients whose last two menstrual cycles prior to randomization enrollment each fall within a range of 30+/-5 days.
- •Patients who have a degree of 3 points or more of dysmenorrhea score during the menstrual cycle of the screening period.
排除标准
- •Patients with a complication of lower abdominal pain or lumber pain the cause of which can not be ruled out as dysmenorrhea.
- •Patients with a complication or history of thrombophlebitis, pulmonary embolism, cerebral vascular disorder or coronary artery disease. Patients with a predisposing factor of thrombosis.
- •Patients who are pregnant or possibly pregnant or nursing mother, or patients who cannot comply with contraception during the study period.
结局指标
主要结局
-
Efficacy: Change in dysmenorrhea score Safety: Adverse events Genital haemorrhage
次要结局
- Change in VAS score for painful symptom
- Changes in pelvic pain score
研究者
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