NCT00401193已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
研究概览
简要总结
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with menorrhagia
- •18-49 years of age
- •Regularly occurring menstrual periods
排除标准
- •History or presence of clinically significant disease or abnormalities that may confound the study
- •History of bilateral oophorectomy or hysterectomy
- •Hormone therapy for birth control
研究组 & 干预措施
1
Experimental
干预措施: Tranexamic acid tablets (Drug)
2
Experimental
干预措施: Tranexamic acid tablets (Drug)
3
Placebo Comparator
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Mean Reduction From Baseline in Menstrual Blood Loss (MBL)
时间窗: Baseline MBL over 3 menstrual cycles
reduction of menstrual blood loss in mL
次要结局
- Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding(Baseline scores over 3 menstrual cycles)
- Responder Analysis - Reduction in Large Stains(Baseline over 3 mentrual cycles)
- Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding(Baseline scores over 3 menstrual cycles)
研究者
研究点 (1)
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