临床试验/NCT00225186

NCT00225186已完成3 期

A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)

Bayer0 个研究点目标入组 168 人开始时间: 2004年7月最近更新: 2014年1月9日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 168
主要终点: Safety assessment of the drug

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for 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: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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 or 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 (SH T00660AA , BAY86-5258) (Drug)

结局指标

主要结局

Safety assessment of the drug

时间窗: 12-18 months

次要结局

Efficacy (reduction of pelvic pain)(12-18 months)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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