Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Inclusion Criteria:

• sexually active women requesting contraception
• Regular menses every 24 - 35 days
• In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values

Exclusion Criteria:

• Known or suspected pregnancy
• Lactating women
• Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
• Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
• Use of other contraceptive methods than study medication