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)
Condition: Contraception
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed 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.
    

Intervention name(s): levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2; levonorgestrel patch with BMI <32 kg/m2; levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2; levonorgestrel patch with BMI <32 kg/m2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6.5mg patch daily for 11 weeks; 6.5mg patch daily for 11 weeks; 12.5mg patch daily for 11 weeks; 12.5mg patch daily for 11 weeks
Other intervention name(s): AG 1000-6.5; AG1000-6.5; AG1000-12.5; AG1000-12.5
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention