NCT00225199已完成3 期
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 198
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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
- Double (Participant, Investigator)
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
- •Female patients with endometriosis-associated pelvic pain
排除标准
- •Pregnant or lactating women
- •history or suspicion of hormone dependent tumor
- •therapy resistant endometriosis
- •need for primary surgical treatment
- •any other conditions which forbid the participation.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Visanne (BAY86-5258, SH T00660AA) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy
时间窗: Assessment of pain relief at end of treatment
次要结局
- Adverse event collection(Assessment at end of study)
- Treatment satisfaction by patient(Assessment at end of study)
研究者
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