A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)

Study Summary

WHAT IS THE STUDY PRODUCT? The study product is a contraceptive patch, which has the study drug on the patch. The patch is applied directly to the skin and it contains Levonorgestrel (LNG) in a time-release form. LNG is a hormone that has been tested and been approved by the Food \& Drug Administration (FDA) in other forms, for example: contraceptive pills, intrauterine devices (IUDs, which are put in the uterus (womb)) and implants (drug in silicon tubing placed under the skin). The use of LNG in the form of a contraceptive patch makes this an experimental drug because the way the drug will be absorbed in the body is a new technique. This study drug does not contain estrogen and it does not protect against HIV, AIDS, or any other sexually transmitted diseases (STDs). LNG is a progestin (a type of drug that is like a hormone. Progestins can cause changes at the opening of the uterus (womb), such as thickening of the cervical mucus (fluid). This thickened cervical mucus makes it difficult for the male's sperm to reach and fertilize the woman's egg. Since LNG is being absorbed through your skin from the patch, it is experimental, and it is unknown if this study product will really prevent pregnancy like other progestins. WHY IS THIS STUDY BEING DONE? The purpose of this study is to find out: * How well the patch prevents pregnancy * How safe the patch is to use every day * How much study drug needs to be in the patch to make sure that it prevents pregnancy * How the study drug in the patch affects cervical mucus (fluids) * How the study drug in the patch affects your rate of ovulation (how often you release an egg) * How well the patch sticks to your skin, without falling off, for a week at a time * Whether the patch causes any skin irritation or rash (redness or itchiness) * Whether the study drug in the patch affects your everyday life and if it causes any side effects. WHAT DOES THE STUDY INVOLVE? We expect that there will be approximately twenty (20) women at

Primary Outcome

The primary endpoint is a subject's incidence of the "Poor" cervical mucus score as determined by the modified Insler score. The cervical mucus score will be based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible modified Insler cervical mucus score of 12 (3, 4). The total modified Insler cervical mucus scores of 0-4, 5-8 and 9-12 will be categorized as "Poor," "Fair" and "Good," respectively.

Interventions

• DRUG levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2
• DRUG levonorgestrel patch with BMI <32 kg/m2