Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System

A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)

Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.

Inclusion Criteria:

• Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
• Ability to demonstrate willingness to participate and adhere to study protocol

Exclusion Criteria:

• Known or suspected pregnancy
• Lactating women
• Anticipates use of condoms or any other form of back-up contraception during the study
• History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
• Has a contraindication to combined estrogen-progestin contraceptive use
• Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
• Smoker who is 35 years old or over