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