Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

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

Influence of different application sites on the blood levels after administration of a fertility control patch

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)