EUCTR2008-007024-26-DE进行中（未招募）不适用
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 gestogene (material no. 80876395) in a 21-day regimen as compared to a monophasic contraceptive containing ethinyestradiol and levonogestrel (0.33 mg/0.15 mg) in a 21-day regimen on hemostatic parameters in 30 women aged 18-35 years over 3 treatment cycles in each period - FC-Patch Metabolism Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- signed and dated informed consent
- •- healthy women requesting contrception
- •- age:18-35 years (inclusive), Smokers must be not older than 30 years at the time of informed consent
- •- normal cervical smear not requiring further follow-up
- •- history of regular cyclic menstrual periods
- •- willingness to use back-up contraception during the 2 washout cycles
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
- •- obesity (Body Mass Index >30.0 kg/m2)
- •- hypersensitivity to any ingredient of the study drug
- •- significant skin reaction to transdermal preparations or sensitivity to medical tape
- •- safety relevant laboratory values outside inclusion range before start of treatment
- •- diseases or conditions that can compromise the function of the body systems, may worsen under hormonal treatment or might interfere with the conduct of the study
- •- undiagnosed abnormal genital bleeding
- •- abuse of alcohol, drugs or medicines
- •- any medication that could result in excessive accumulation, impaired metabolism or altered excretion of the study drug or interfere with the contact of the study
- •- major surgery planned during study period
研究者
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