NCT01559480已完成不适用
A Prospective Double Blind Randomized Controlled Trial to Study the Effectiveness of a Desogestrel for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
Endometriosis is one of the most common disease in reproductive aged women.Surgical intervention has a significant symptoms relief. However, symptom recurrence is often after surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary outcome measurement is pain score at 6 months after surgery.
详细描述
After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnoses endometriosis
- •Plan conservative surgery
- •initial pain score at least 5
- •voluntary to be the participant of this study with inform consent
- •No desired child bearing in 6 months
排除标准
- •residual lesion after surgery which required further treatment
- •cannot participate complete 6 months after surgery
- •contraindication for Desogestrel, Paracetamol or Ponstan
研究组 & 干预措施
Desogestrel
Active Comparator
干预措施: Desogestrel (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain score
时间窗: 6 months
Pain score will be assessed by visual analog scale (0-10)
次要结局
- Side effect compared between both group(6 month)
- Patients satisfaction compare between both groups(6 months)
研究者
研究点 (2)
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