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)
Public ClinicalTrials.gov record NCT01166412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01166412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Interventions
- levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 Drug
- levonorgestrel patch with BMI <32 kg/m2 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 44 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- Jun 30, 2012
- Completion
- Jun 30, 2012
- Last update posted
- Jan 6, 2026
2010 – 2012
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado - Adv. Repro. Med. | Aurora | Colorado | 80045 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | — |
| Oregon Health Sciences University | Portland | Oregon | 97239 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01166412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01166412 live on ClinicalTrials.gov.