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) — CCN009  

Contraception Clinical Trial

Official title: CCN009: A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate the Effects on the Mechanisms of Contraceptive Efficacy and, Secondarily, to Assess the Pharmacokinetic Profile and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a Phase I/II, multi-center, open-label, randomized, parallel group, pharmacokinetic, pharmacodynamic study of the AG1000-6.5 and AG1000-12.5 transdermal contraceptive delivery systems (TCDS) in healthy women followed as an outpatient for up to three 28-day cycles (12 weeks or approximately 3 months). During this study, subjects will receive active treatment with the LNG TCDS patches for 11 weeks, followed by one week of post-treatment assessment. The TCDS is designed for one week of patch wear. This study will be conducted by the National Institute of Child Health and Human Development (NICHD) in its Contraceptive Clinical Trials Network (CCTN) at 6 sites in the USA and will enroll approximately 120 women.

This study will enroll approximately 120 subjects, who will be randomized across all sites into the two treatment groups (~60 subjects at each dose level). The randomization schedule will be further stratified to ensure enrollment of approximately 50% of subjects with BMI >32 kg/m2 and <40 kg/m2 and approximately 50% of subjects with BMI <32 kg/m2 for each dose level. ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT01166412
• Study type: Interventional
• Source: Health Decisions
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2010
• Completion date: July 2012