Russia/Ukraine Suppression of Ovarian Activity Study

Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles

The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.

Inclusion Criteria:

• Healthy female subjects requesting contraception
• Aged 18 to 35 years (inclusive); smokers must not be older than 30 years
• Normal or clinically insignificant cervical smear not requiring further follow-up
• History of regular cyclic menstrual periods
• Willingness to use nonhormonal methods of contraception during the entire study
• Proven ovulation upon completion of the pretreatment cycle

Exclusion Criteria:

• Pregnancy or lactation
• Obesity (body mass index [BMI] > 30.0 kg/m2)
• Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
• Any disease or condition that may worsen under hormonal treatment
• Use of hormonal contraception other than study medication during the study