AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol

This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with
AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch
wear followed by a patch-free week).

Part II employs crossover design with subjects randomly assigned to one of the two treatment
sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as
described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive,
Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed
by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day
regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of
each treatment Period is 28 days (one cycle of therapy).

Inclusion Criteria:

- Healthy women, ages 18-45

- Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.

- Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have
already undergone previous bilateral tubal ligation or hysterectomy

- Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until
completion of each treatment period

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

- Smokers