临床试验/NCT00624130

NCT00624130已完成3 期

Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

Bayer0 个研究点目标入组 453 人开始时间: 2004年3月最近更新: 2014年12月31日

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: 453
主要终点: Cycle control and bleeding pattern

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 compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy female volunteer aged 18-35,
•Smokers 18-30

排除标准

•Contraindications for using hormonal contraceptives

研究组 & 干预措施

Arm 1

Experimental

干预措施: Yasmin 20 (Drug)

Arm 2

Active Comparator

干预措施: Mercilon (Drug)

结局指标

主要结局

Cycle control and bleeding pattern

时间窗: 7 cycles

次要结局

Body weight(Screening, admission)
Vital signs(Screening, admission)
Laboratory tests(Screening)
Adverse Events(7 cycles)
General Physical and gynecological examinations(Screening)
Pearl index(7 cycles)

研究者

发起方

申办方类型

Industry

责任方

Sponsor

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