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)

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 each of the six (6) participating clinics in the study. In total, there will be about 120 women from all over the United States who will be in this study. This study is comparing the effectiveness of two different doses of the study drug (40ug and 75 ug) in the patches. This study is an open-label randomized trial, meaning that you and your study doctor will be aware of the dosage of study drug that you will be given. Randomization means that you will be selected by chance, like tossing a coin or rolling a dice. You have a 50% chance of being in the group that receives the 40ug dose patch or the group that receives 75ug dose patch.

Conditions

• Contraception

Interventions

DRUG

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

6.5mg patch daily for 11 weeks

DRUG

levonorgestrel patch with BMI <32 kg/m2

6.5mg patch daily for 11 weeks

DRUG

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

12.5mg patch daily for 11 weeks

DRUG

levonorgestrel patch with BMI <32 kg/m2

12.5mg patch daily for 11 weeks

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Premier Research

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2012-07-31

Completion

2012-07-31

Countries

• United States

Study Locations