NCT00896571已完成2 期
Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 92
- 主要终点
- Effect on the endometrium at cycle 13
研究概览
简要总结
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.
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
- 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
- •Requiring contraception
- •Normal cervical smear
- •Smokers not older than 30 years
- •History of regular cyclic menstrual periods
排除标准
- •Pregnancy or lactation
- •Obesity (BMI> 30 kg/m2)
- •Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- •Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- •Use of other contraceptive methods than study medication
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ethinylestradiol/Gestogene (BAY86-5016) (Drug)
结局指标
主要结局
Effect on the endometrium at cycle 13
时间窗: 13 treatment cycles (each consisting of 28 days)
次要结局
- Cervical smear(13 treatment cycles (each consisting of 28 days))
- Adverse events(13 treatment cycles (each consisting of 28 days))
- Cycle control(13 treatment cycles (each consisting of 28 days))
- Safety laboratory(13 treatment cycles (each consisting of 28 days))
- Occurence of pregnancy(13 treatment cycles (each consisting of 28 days))
研究者
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