临床试验/NCT00367276

NCT00367276已完成3 期

A Multicentre, Open, Uncontrolled Study to Assess Quality of Life During Six Cycles (24 Weeks) of Treatment With an Oral Contraceptive Containing 30 µg of Ethinylestradiol and 3 mg of Drospirenone (Yasmin).

Bayer0 个研究点目标入组 221 人开始时间: 2002年12月最近更新: 2013年10月11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: 221
主要终点: Change of Psychological General Well Being Questionnaire score

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 evaluate the effects on the quality of life and BMI of new contraceptives.

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 35 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Female requiring contraceptives.
•Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
•Regular menstrual cycle (defined as duration of 28 +/- 5 days).

排除标准

•No Contraindication for OC use

研究组 & 干预措施

Arm 1

Experimental

干预措施: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) (Drug)

结局指标

主要结局

Change of Psychological General Well Being Questionnaire score

时间窗: pretreatment cycle to cycle 6

次要结局

Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)(pretreatment to cycle 6)
Subject satisfaction with treatment at final visit(at final visit)
Subject evaluation of changes in greasy skin and greasy hair(baseline to cycle 6)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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