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NCT01166412 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Premier Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
NCT01166412 is a Phase 1 study that has completed, run by Premier Research. The registered enrollment target is 121 participants.
The verdict
NCT01166412, a Phase 1 study, has completed, sponsored by Premier Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
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
Interventions
- DRUG levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2
- DRUG levonorgestrel patch with BMI <32 kg/m2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166412
The ClinicalTrials.gov registry entry for NCT01166412 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Premier Research, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 is the first listed.
NCT01166412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01166412 about?
NCT01166412 is a clinical study titled "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)". 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 Administrat...
What is the current status of trial NCT01166412?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2010-12. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01166412?
The interventions under investigation include: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 (DRUG), levonorgestrel patch with BMI <32 kg/m2 (DRUG).
Who is sponsoring clinical trial NCT01166412?
This trial is sponsored by Premier Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
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