NCT01083264已完成1 期
Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Transdermally Administered Ethinylestradiol (EE) and Gestodene (GSD) After Repeated Applications of a Fertility Control Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene to 3 Different Application Sites (Buttocks, Arm Versus Abdomen) in Healthy Young Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 43
- 主要终点
- AUC(0-168) for EE and Gestodene during week 4 of each treatment period
研究概览
简要总结
Influence of different application sites on the blood levels after administration of a fertility control patch
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female subjects
- •Age 18-45 years
- •Body mass index (BMI) 18-30kg/m²
- •At least 3 months since delivery, abortion, or lactation before the first screening examination
- •Ability to understand and follow study-related instructions
- •Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods
排除标准
- •Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
- •Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
- •Regular use of medicines other than contraceptives
- •Smokers (at the age of 31 to 45 years)
- •Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
Arm 2
Experimental
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
Arm 3
Experimental
干预措施: Gestodene/EE Patch (BAY86-5016) (Drug)
结局指标
主要结局
AUC(0-168) for EE and Gestodene during week 4 of each treatment period
时间窗: Week 4 of each treatment period ( 3 periods)
次要结局
- Adverse Events(Week 1-5 of each treatment period)
- Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week(Week 1-5 of each treatment period)
研究者
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