临床试验/NCT00185289

NCT00185289已完成3 期

Multi-center , Open, Uncontrolled Study to Investigate the Efficacy and Safety of a 4 Phasic Oral Contraceptive SH T00658 in a 28-day Regimen for 20 Cycles in Healthy Female Volunteers

Bayer50 个研究点分布在 3 个国家目标入组 1,392 人开始时间: 2004年4月最近更新: 2011年7月15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: 1,392
试验地点: 50
主要终点: Number of unintended pregnancies

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研究点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 evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.

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: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy volunteers

排除标准

•Any condition that might interfere the outcomes

研究组 & 干预措施

Arm 1

Experimental

干预措施: EV/DNG (Qlaira, BAY86-5027, SH T00658K) (Drug)

结局指标

主要结局

Number of unintended pregnancies

时间窗: 20 treatment cycles each consisting of 28 days and follow-up period of 14 days

次要结局

Adverse event collection(20 treatment cycles each consisting of 28 days)

研究者

发起方

Bayer

申办方类型

Industry

研究点 (50)

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