Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

Multicenter, Open-label, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg EE and Either 1.05 or 2.1 mg GSD in Healthy Young Female Vol. 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

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Inclusion Criteria:

• Signed informed consent,
• BMI: 18 - 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/arterial thromboembolic disease
• Regular intake of medication other than OCs
• Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
• Anovulatory pre-treatment cycle