NCT00933179已完成2 期
A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period
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
- 30
- 主要终点
- Prothrombin fragment 1+2, D-dimer
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 parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 woman requesting contraception
- •Normal cervical smear not requiring further follow-up
- •History of regular cyclic menstrual periods
- •Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods
排除标准
- •Pregnancy or lactation - Obesity (Body Mass Index [BMI] > 30.0 kg/m2)
- •Any diseases or conditions that can compromise the function of the body systems
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Any disease or condition that may worsen under hormonal treatment
- •Undiagnosed abnormal genital bleeding
- •Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
研究组 & 干预措施
Arm 1
Experimental
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
Arm 2
Active Comparator
干预措施: EE/Levonorgestrel (Microgynon, BAY86-4977) (Drug)
结局指标
主要结局
Prothrombin fragment 1+2, D-dimer
时间窗: Screening, visit 3-7
次要结局
- Thrombin and Fibrin turnover parameters(Screening, visit 3-7)
- Procoagulatory parameters(Screening, visit 3-7)
- Anticoagulatory parameters(Screening, visit 3-7)
研究者
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