Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

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

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Inclusion Criteria:

• BMI: 18 BMI 30 kg/m²
• Healthy female volunteers
• Age 18-35 years (smoker not older than 30 years, inclusive)
• Ovulatory pre-treatment cycle, at least 3 month since delivery
• Abortion or lactation before the first screening examination
• Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

• Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
• Regular intake of medication other than OCs
• Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle