Multicenter, open-label, randomized, uncontrolled 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, patch, ethinylestradiol and gestodene

Bayer HealthCare AG/Bayer Schering Pharma AG0 个研究点开始时间: 2008年11月24日最近更新: 2013年3月11日

研究概览

暂无简介。

•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
•Body mass index (BMI): 18 = BMI = 30 kg/m²
•At least 3 months since delivery, abortion, or lactation before the first screening examination
•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

•Contraindications for use of a combined (estrogen/progestogen) contraception (e.g. History of venous/arterial thromembolic disease)
•regular intake of medication other than OCs
•Clinically relevant findings (ECG, blood preasure, 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

发起方

Bayer HealthCare AG/Bayer Schering Pharma AG