EUCTR2009-009177-10-DE进行中（未招募）不适用
Multicenter, open-label, randomized study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg ethinylestradiol and either 1.05 or 2.1 mg gestodene in healthy young female volunteers over a period of 3 treatment cycles - Inhibition of ovulation and pharmacokinetics of transdermal EE and GSD
适应症
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 informed consent prior to study participation and confirmation of the volunteer’s health insurance coverage
- •Healthy female volunteer
- •Age: 18 – 35 years (inclusive) at the first screening examination (smokers not older than 30 years, inclusive)
- •Body mass index (BMI): 18 = BMI < = 30 kg/m²
- •At least 3 months since delivery, abortion, or lactation before the screening visit
- •Willingness to use non-hormonal methods of contraception during the entire study
- •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
- •Contraindications for use of a combined (estrogen/progesteron) contraception (e.g. history of venous/arterial thromembolic disease)
- •regular intake of medication other than OCs
- •Clinical relevant findings (heart rate, blood pressure, physical, gynecological examination, laboratory examination)
- •Anovulatory pre-treatment cycle
- •Skin diseases with suspected alteration of dermal resorption and/or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria)
- •Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
研究者
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