临床试验/NCT00988910

NCT00988910已完成不适用

Observational Study on the Effects of DRSP-Containing Combined Oral Contraceptives (Yasmin,Yasminelle) and Other Combined Oral Contraceptives on the General and Sexual Well-Being in COC Users

Bayer0 个研究点目标入组 632 人开始时间: 2008年1月最近更新: 2014年6月26日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 632
主要终点: Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)

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 symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•According to the label of the prescribed Combined Oral Contraceptive (COC)
•first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
•intention to use current COC for 1 year at least

排除标准

•Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)

研究组 & 干预措施

Group 1

干预措施: EE30-DRSP (Yasmin, BAY86-5131) (Drug)

Group 2

干预措施: Other combined oral contraceptives (Drug)

结局指标

主要结局

Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)

时间窗: at 12 months

Sexual well-being evaluated by the Female Sexual Function Index (FSFI)

时间窗: at 12 months

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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