ContraceptionPhase 1/2CCN009NCT01166412
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 1/2 study testing levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 and levonorgestrel patch with BMI <32 kg/m2 in people with Contraception, run by Premier Research at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 and levonorgestrel patch with BMI <32 kg/m2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2010to Jul 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Good general health.
- 2. Aged 18-44 years, inclusive, at the enrollment visit.
- 3. Intact uterus with at least one ovary.
- 4. Pap test within the last 12 months or undergo a Pap test at screening prior to enrollment. If a potential subject states that she has had a Pap test within the last 12 months, then she will need to provide documentation of acceptable test results.
- 5. Cervical mucus score of >7, which is based on the modified Insler scoring system during the screening cycle. The cervical mucus is collected by aspiration and the assessment is based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible score of 12 (3, 4).
- 6. Regular menstrual cycles that occur every 28 ± 7 days.
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- If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles prior to screening.
- If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening.
- 7. Heterosexually abstinent or, if heterosexually active, must have undergone previous tubal sterilization, be in monogamous relationship with a vasectomized partner, or only use male or female condoms (use of condoms that are pre-lubricated with or without spermicide is acceptable) for the entire duration of the study. Use of a spermicide applied separately is not allowed. Cervical caps or diaphragms are not allowed during study participation.
- 8. In the opinion of the investigator, able to comply with the protocol, willing to record requested information in the daily diary, and live within the study site catchment area or within a reasonable distance from the site.
- 9. Understand and sign an IRB approved informed consent form prior to screening activities (including fasting blood draw).
- 10. Willing to refrain from use of skin lotions/creams/gels on area of patch application and not use any vaginal creams, lubricants, gels, or spermicides for 3 days prior to study admission through to the end of the study.
- 11. Agree not to participate in any other clinical trials during the course of this study.
Who cannot join
- Contraindications for enrollment will be the same as those for use of combined hormonal contraceptives as referenced in the World Health Organization (WHO) Medical Eligibility Criteria(MEC category 1 or 2) (1), in addition to contra-indications specific to this clinical trial including:
- 1. Known hypersensitivity or contraindication to progestins.
- 2. Known or suspected pregnancy.
- 3. Prior hysterectomy or bilateral oophorectomy.
- 4. Prior cervical surgery (LEEP, Cone biopsy, Cryosurgery).
- 5. A history (within prior 12 months) or drug or alcohol abuse.
Show all 34Show fewer
- 6. Undiagnosed abnormal genital bleeding.
- 7. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may not be included in the trial unless they are treated and proof of cure is documented after treatment (i.e. repeat test with negative results). In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.
- 8. Uncontrolled thyroid disorder.
- 9. History or presence of dermal hypersensitivity in response to topical application. Specifically any reaction to application of a plastic bandage (Band-Aid), surgical or bandage tape, other skin patches, or adhesives.
- 10. Any Pap test finding that would require additional workup or treatment during the study interval. HPV testing will not be done at screening for these subjects.
- 11. Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10 months.
- 12. Use of oral contraceptives, contraceptive implants, or other sex steroid hormones within 30 days prior to screening visit.
- 13. Women who are breastfeeding or within 30 days of discontinuing breast feeding.
- 14. Women planning to undergo major surgery within four months of study enrollment.
- 15. Women planning pregnancy within their months of study enrollment.
- 16. Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism.
- 17. Current or past deep vein thrombophlebitis or thromboembolic disorders.
- 18. History of known thrombophilia in a first-degree relative <45 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk.
- 19. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis.
- 20. History of retinal vascular lesions, unexplained partial or complete loss of vision.
- 21. Known or suspected carcinoma of the breast, endometrium, or any other known or suspected progestin-dependent neoplasia.
- 22. Past history of any other carcinoma (excluding basal cell carcinomas) unless in remission for more than 5 years.
- 23. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication.
- 24. Headaches with focal neurological symptoms only in women over 35 years old.
- 25. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or other benign or malignant liver tumors; active liver disease.
- 26. Systolic BP > 140 mm Hg and/or Diastolic blood pressure (BP) > 90 mm Hg after 5-10 minutes rest.
- 27. Clinically significant abnormal serum chemistry values according to the Principal Investigator's judgment.
- 28. Participation in another clinical trial involving an investigational drug or device within last 30 days (prior to screening).
- 29. Use of liver enzyme inducers within last 90 days (prior to screening) or intention to use liver enzyme inducers during the study (see Appendix 2 Exclusionary Medication List).
- 30. Known HIV infection.
- 31. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. Women enrolled in the study, who use condoms to protect against STIs or pregnancy, should be instructed that they can use condoms that are pre-lubricated with spermicide or lubricated, but they cannot use a spermicide applied separately and they should record all condom use in their diaries.
- 32. Women who use any medications on the Exclusionary Medication List (see Appendix 2) OR used any within the past three months prior to the screening visit.
- 33. Women with BMI ≥40 kg/m2 are excluded.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado - Adv. Repro. Med.
Aurora, Colorado, 80045
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Columbia University
New York, New York, 10032
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97239
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2, levonorgestrel patch with BMI <32 kg/m2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2Drug
Also called AG 1000-6.5
6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI <32 kg/m2Drug
Also called AG1000-6.5
6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2Drug
Also called AG1000-12.5
12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI <32 kg/m2Drug
Also called AG1000-12.5
12.5mg patch daily for 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose level AG1000-6.5 | Active comparator | Not described Receives: Drug: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2; Drug: levonorgestrel patch with BMI <32 kg/m2 |
| Dose level AG1000-12.5 | Active comparator | Not described Receives: Drug: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2; Drug: levonorgestrel patch with BMI <32 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Poor Cervical Mucus Scores During Treatment Period
The primary endpoint is a subject's incidence of the "Poor" cervical mucus score as determined by the modified Insler score. The cervical mucus score will be based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible modified Insler cervical mucus score of 12 (3, 4). The total modified Insler cervical mucus scores of 0-4, 5-8 and 9-12 will be categorized as "Poor," "Fair" and "Good," respectively.
Measured: Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)
Secondary outcomes (15)
Changes From Baseline in Endometrial Thickness
Changes from Baseline in endometrial thickness measured at Visit 1, Visits 3-5, Visits 7-10, Visit 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Measured: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Patch Wearability Based on Patch Adhesion
Patch wearability measured by patch adhesion at Visit 4, Visit 6, Visit 8, Visit 10, Visits 12-18 (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78) based on the following criteria: > 90% = > 90% of patch adhered (no lift from skin); >75% but < 90% = > 75% adhered but < 90% (some edges showing lift from skin); > 50% but < 75% = > 50% adhered but < 75% (half of patch lifts of skin; < 50% = < 50% adherence ( > half of patch lifts off, but not detached); Patch Off = patch completely detached from skin
Measured: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed
LNG PK at 0, 1, 2, 4, and 6 hours with patch on Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12) after patch removal using Area Under the Curve Mean at each visit. The mean area under the curve represents the amount of LNG in the body at the given timepoint.
Measured: Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12), up to 78 days
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Serum LNG measures at Day 2 (Visit 2), Day 8 (Visit 4), Day 15 (Visit 6), Day 22 (Visit 8), Days 30, 36, 43, 50, 57, 64, 71 (Visits 11-17), Days 79, 80, 81, 82, 85 (Visits 19-23)
Measured: Treatment Days 2, 8, 15, 22, 30, 36, 43, 50, 57, 64, 71, 79, 80, 81, 82, and 85, up to 85 days
Changes From Baseline in Estradiol Levels
Changes from Baseline (Visit 1) in Estradiol levels measured at Visits 3-10, Visit 12-18, Visit 23 (Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85)
Measured: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 days
Changes From Baseline in Luteinizing Hormone Levels
Changes from Baseline (Visit 1) in LH levels measured at Visits 3-10, Visit 12-18, Visit 23 (Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85)
Measured: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 days
Changes From Baseline in Follicle-Stimulating Hormone Levels
Changes from Baseline (Visit 1) in FSH levels measured at Visits 10/Day 29, Visit 15/Day 57, Visit 18/Day 78, Visit 23/Day 85
Measured: Days 0, 29, 57, 78, 85, up to 85 days
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Changes from Baseline (Visit 1) in SHBG levels measured at Visits 10/Day 29, Visit 15/Day 57, Visit 18/Day 78, Visit 23/Day 85
Measured: Days 0, 29, 57, 78, 85, up to 85 days
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Number of follicles greater than or equal to 6mm at Baseline, Visits 1-10, Visits 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Measured: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Maximum diameter of largest ovarian follicle measured at Baseline, Visits 1-10, Visits 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Measured: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Average diameter of largest ovarian follicle measured at Baseline, Visits 1-10, Visits 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Measured: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Number of subjects that possibly ovulated based on serum progesterone > 3.0 ng/mL but <10 ng/mL measured during Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12
Measured: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks
Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Number of subjects that possibly ovulated based on serum progesterone > 10 ng/mL measured during Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12
Measured: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks
Bleeding Patterns Based on Number of Bleeding/Spotting Days
Bleeding and spotting days are recorded via subject diary and the number of days of bleeding and spotting are assessed during Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12
Measured: Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12, up to 12 Weeks
Patch Wearability Based on Skin Irritation
Patch wearability measured by patch site skin irritation at Visit 4, Visit 6, Visit 8, Visit 10, Visits 12-18 (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78) based on the following criteria: None= No irritation or barely perceptible/spotty erythema; Mild= Mild erythema covering approximately <50% of the application site; Moderate = Moderate erythema covering approximately >=50% of the application site, possible presence of mild edema; Significant = Severe erythema, possible edema, vesiculation, bullae and/or ulceration.
Measured: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premier Research
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166412
- Sponsor's protocol ID
- CCN009
- Acronym
- CCN009
- Status last verified
- Dec 2025
- First submitted
- 19 Jul 2010
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01166412
- Acronym / sponsor ID
- CCN009 / CCN009
- Conditions
- Contraception
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Premier ResearchUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose level AG1000-6.5 | Active comparator | Drug: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2, Drug: levonorgestrel patch with BMI <32 kg/m2 |
| Dose level AG1000-12.5 | Active comparator | Drug: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2, Drug: levonorgestrel patch with BMI <32 kg/m2 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 1. Good general health.
- 2. Aged 18-44 years, inclusive, at the enrollment visit.
- 3. Intact uterus with at least one ovary.
- 4. Pap test within the last 12 months or undergo a Pap test at screening prior to enrollment. If a potential subject states that she has had a Pap test within the last 12 months, then she will need to provide documentation of acceptable test results.
- 5. Cervical mucus score of >7, which is based on the modified Insler scoring system during the screening cycle. The cervical mucus is collected by aspiration and the assessment is based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible score of 12 (3, 4).
Key exclusion criteria (34 listed)
- Contraindications for enrollment will be the same as those for use of combined hormonal contraceptives as referenced in the World Health Organization (WHO) Medical Eligibility Criteria(MEC category 1 or 2) (1), in addition to contra-indications specific to this clinical trial including:
- 1. Known hypersensitivity or contraindication to progestins.
- 2. Known or suspected pregnancy.
- 3. Prior hysterectomy or bilateral oophorectomy.
- 4. Prior cervical surgery (LEEP, Cone biopsy, Cryosurgery).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2Also: AG 1000-6.56.5mg patch daily for 11 weeks | Drug | Dose level AG1000-6.5 |
| levonorgestrel patch with BMI <32 kg/m2Also: AG1000-6.56.5mg patch daily for 11 weeks | Drug | Dose level AG1000-6.5 |
| levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2Also: AG1000-12.512.5mg patch daily for 11 weeks | Drug | Dose level AG1000-12.5 |
| levonorgestrel patch with BMI <32 kg/m2Also: AG1000-12.512.5mg patch daily for 11 weeks | Drug | Dose level AG1000-12.5 |
Primary outcome
Number of Subjects With Poor Cervical Mucus Scores During Treatment Period
Time frame: Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)
The primary endpoint is a subject's incidence of the "Poor" cervical mucus score as determined by the modified Insler score. The cervical mucus score will be based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible modified Insler cervical mucus score of 12 (3, 4). The total modified Insler cervical mucus scores of 0-4, 5-8 and 9-12 will be categorized as "Poor," "Fair" and "Good," respectively.
15 secondary outcomes
Changes From Baseline in Endometrial Thickness
Time frame: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Patch Wearability Based on Patch Adhesion
Time frame: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed
Time frame: Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12), up to 78 days
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Time frame: Treatment Days 2, 8, 15, 22, 30, 36, 43, 50, 57, 64, 71, 79, 80, 81, 82, and 85, up to 85 days
Changes From Baseline in Estradiol Levels
Time frame: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 days
Changes From Baseline in Luteinizing Hormone Levels
Time frame: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 days
Changes From Baseline in Follicle-Stimulating Hormone Levels
Time frame: Days 0, 29, 57, 78, 85, up to 85 days
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Time frame: Days 0, 29, 57, 78, 85, up to 85 days
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Time frame: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Time frame: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Time frame: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Time frame: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks
Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Time frame: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks
Bleeding Patterns Based on Number of Bleeding/Spotting Days
Time frame: Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12, up to 12 Weeks
Patch Wearability Based on Skin Irritation
Time frame: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 and levonorgestrel patch with BMI <32 kg/m2 in people with Contraception, run by Premier Research at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Poor Cervical Mucus Scores During Treatment Period (time frame: Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.