CompletedNCT01166412CCN009Updated Jan 7, 2026Results posted

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 interventional study of levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 and levonorgestrel patch with BMI <32 kg/m2 in Contraception, sponsored by Premier Research. Completed at 6 sites in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Premier Research · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 121
Allocation: Randomized
Ages: 18 Years to 44 Years
Sex: Female

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 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 studied

Contraception

Who can participate

Ages eligible: 18 Years to 44 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

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.
1. 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.
2. 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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 121 participants (actual)

Study arms

Active comparator
Dose level AG1000-6.5
Drug: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 · Drug: levonorgestrel patch with BMI <32 kg/m2
Active comparator
Dose level AG1000-12.5
Drug: levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2 · Drug: levonorgestrel patch with BMI <32 kg/m2

Interventions

Druglevonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2
6.5mg patch daily for 11 weeks
Also known as: AG 1000-6.5
Druglevonorgestrel patch with BMI <32 kg/m2
6.5mg patch daily for 11 weeks
Also known as: AG1000-6.5
Druglevonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2
12.5mg patch daily for 11 weeks
Also known as: AG1000-12.5
Druglevonorgestrel patch with BMI <32 kg/m2
12.5mg patch daily for 11 weeks
Also known as: AG1000-12.5

What researchers measure

Primary outcomes

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.
Time frame: Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)

Secondary outcomes

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)
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
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
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
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.
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.
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)
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
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)
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
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)
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
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
Time frame: 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
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
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)
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
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)
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
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)
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)
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
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)
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
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
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
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
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.
Time frame: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days

Results

Posted Jan 7, 2026

Participant flow

Participant flow — Overall Study
Milestone	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Started	61	60
Completed	56	48
Not completed	5	12

Outcome measures

PrimaryNumber 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.

Time frame:: Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)
Reported as:: Count of participants · Participants

Number of Subjects With Poor Cervical Mucus Scores During Treatment Period
Participants	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Number of Subjects With Poor Cervical Mucus Scores During Treatment Period	3	11

SecondaryChanges 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)

Time frame:: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Reported as:: Mean · mm

Changes From Baseline in Endometrial Thickness
mm	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	7.68 ± 3.243	7.90 ± 2.792
Change from Baseline to Visit 1/Day 1	-2.94 ± 3.885	-3.32 ± 3.730
Change from Baseline to Visit 3/Day 5	-2.77 ± 3.377	-3.15 ± 2.936
Change from Baseline to Visit 4/Day 8	-1.75 ± 3.706	-2.00 ± 3.121
Change from Baseline to Visit 5/Day 11	-0.71 ± 3.239	-2.50 ± 3.673
Change from Baseline to Visit 7/Day 18	-0.91 ± 4.367	-2.16 ± 3.216
Change from Baseline to Visit 8/Day 22	-1.34 ± 3.960	-2.69 ± 3.384
Change from Baseline to Visit 9/Day 25	-1.97 ± 3.834	-2.87 ± 3.769
Change from Baseline to Visit 10/Day 29	-2.67 ± 3.234	-3.26 ± 3.413
Change from Baseline to Visit 12/Day 36	-2.10 ± 3.995	-3.16 ± 3.436
Change from Baseline to Visit 13/Day 43	-1.67 ± 3.837	-3.18 ± 3.183
Change from Baseline to Visit 14/Day 50	-1.72 ± 4.422	-3.24 ± 3.456
Change from Baseline to Visit 15/Day 57	-2.18 ± 3.940	-3.80 ± 3.477
Change from Baseline to Visit 16/Day 64	-2.26 ± 3.676	-3.39 ± 3.637
Change from Baseline to Visit 17/Day 71	-2.08 ± 4.175	-3.56 ± 3.224
Change from Baseline to Visit 18/Day 78	-1.95 ± 3.857	-2.84 ± 3.526

SecondaryPatch 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

Time frame:: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Reported as:: Count of participants · Participants

Patch Wearability Based on Patch Adhesion
Participants	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Visit 4/Day 8: >90%	49	50
Visit 4/Day 8: 75-90%	9	7
Visit 4/Day 8: 50-75%	1	0
Visit 4/Day 8: <50%	0	0
Visit 4/Day 8: Patch Off	1	1
Visit 6/Day 15: >90%	52	46
Visit 6/Day 15: 75-90%	6	9
Visit 6/Day 15: 50-75%	0	1
Visit 6/Day 15: <50%	0	0
Visit 6/Day 15: Patch Off	0	1
Visit 8/Day 22: >90%	54	46
Visit 8/Day 22: 75-90%	4	7
Visit 8/Day 22: 50-75%	0	0
Visit 8/Day 22: <50%	0	1
Visit 8/Day 22: Patch Off	1	1
Visit 10/Day 29: >90%	56	44
Visit 10/Day 29: 75-90%	2	8
Visit 10/Day 29: 50-75%	0	1
Visit 10/Day 29: <50%	0	0
Visit 10/Day 29: Patch Off	0	0
Visit 12/Day 36: >90%	53	47
Visit 12/Day 36: 75-90%	4	3
Visit 12/Day 36: 50-75%	0	3
Visit 12/Day 36: <50%	0	0
Visit 12/Day 36: Patch Off	2	1
Visit 13/Day 43: >90%	51	46
Visit 13/Day 43: 75-90%	6	4
Visit 13/Day 43: 50-75%	0	1
Visit 13/Day 43: <50%	0	0
Visit 13/Day 43: Patch Off	0	0
Visit 14/Day 50: >90%	55	42
Visit 14/Day 50: 75-90%	2	8
Visit 14/Day 50: 50-75%	0	0
Visit 14/Day 50: <50%	0	0
Visit 14/Day 50: Patch Off	0	0
Visit 15/Day 57: >90%	51	44
Visit 15/Day 57: 75-90%	5	4
Visit 15/Day 57: 50-75%	0	0
Visit 15/Day 57: <50%	0	0
Visit 15/Day 57: Patch Off	1	1
Visit 16/Day 64: >90%	51	43
Visit 16/Day 64: 75-90%	5	4
Visit 16/Day 64: 50-75%	0	0
Visit 16/Day 64: <50%	0	0
Visit 16/Day 64: Patch Off	0	1
Visit 17/Day 71: >90%	54	45
Visit 17/Day 71: 75-90%	3	4
Visit 17/Day 71: 50-75%	0	0
Visit 17/Day 71: <50%	0	0
Visit 17/Day 71: Patch Off	0	0
Visit 18/Day 78: >90%	53	40
Visit 18/Day 78: 75-90%	3	5
Visit 18/Day 78: 50-75%	0	0
Visit 18/Day 78: <50%	0	0
Visit 18/Day 78: Patch Off	0	3

SecondaryLNG 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.

Time frame:: Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12), up to 78 days
Reported as:: Mean · hr*pg/mL

LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed
hr*pg/mL	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Day 1/Visit 1	322.6247 ± 141.24822	401.3429 ± 200.31346
Day 29/Visit 5	1326.6995 ± 1663.88816	1997.9708 ± 1626.87132
Day 78/Visit 12	945.0963 ± 590.16226	1303.4188 ± 781.29795

SecondarySingle 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)

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
Reported as:: Mean · ng/mL

Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
ng/mL	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Day 2	181.489 ± 174.4023	392.703 ± 354.6305
Day 8	183.140 ± 143.5979	301.107 ± 181.3892
Day 15	175.092 ± 123.0980	290.184 ± 212.5369
Day 22	174.769 ± 126.9624	349.906 ± 259.7689
Day 30	276.579 ± 247.4270	519.327 ± 398.7602
Day 36	178.315 ± 135.2644	309.459 ± 320.7415
Day 43	168.591 ± 136.0588	301.725 ± 218.2762
Day 50	174.454 ± 143.7253	330.625 ± 282.0871
Day 57	176.129 ± 133.7951	272.921 ± 171.9373
Day 64	162.538 ± 130.8442	276.387 ± 198.0998
Day 71	167.253 ± 128.7246	280.677 ± 177.6261
Day 79	100.182 ± 54.7594	129.584 ± 76.1130
Day 80	72.311 ± 41.8869	87.295 ± 53.3175
Day 81	48.481 ± 22.9973	66.773 ± 37.6578
Day 82	37.506 ± 22.2807	49.627 ± 25.1602
Day 85	29.554 ± 25.5765	38.882 ± 38.1462

SecondaryChanges 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)

Time frame:: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 days
Reported as:: Mean · pg/mL

Changes From Baseline in Estradiol Levels
pg/mL	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	44.1 ± 16.61	47.2 ± 48.40
Change from Baseline to Visit 3/Day 5	44.7 ± 66.19	43.8 ± 60.55
Change from Baseline to Visit 4/Day 8	119.4 ± 108.95	103.2 ± 138.77
Change from Baseline to Visit 5/Day 11	158.4 ± 166.04	170.7 ± 207.28
Change from Baseline to Visit 6/Day 15	147.1 ± 143.95	191.9 ± 249.75
Change from Baseline to Visit 7/Day 18	129.1 ± 122.25	123.8 ± 164.50
Change from Baseline to Visit 8/Day 22	71.5 ± 107.17	76.6 ± 120.61
Change from Baseline to Visit 9/Day 25	33.8 ± 78.86	65.0 ± 121.64
Change from Baseline to Visit 10/Day 29	21.4 ± 55.67	37.8 ± 98.50
Change from Baseline to Visit 12/Day 36	101.6 ± 150.53	53.9 ± 110.20
Change from Baseline to Visit 13/Day 43	113.4 ± 173.71	98.6 ± 172.48
Change from Baseline to Visit 14/Day 50	85.7 ± 118.49	73.7 ± 166.09
Change from Baseline to Visit 15/Day 57	76.4 ± 135.90	40.1 ± 117.25
Change from Baseline to Visit 16/Day 64	94.5 ± 165.60	42.4 ± 104.84
Change from Baseline to Visit 17/Day 71	82.6 ± 114.90	51.3 ± 99.92
Change from Baseline to Visit 18/Day 78	73.2 ± 101.43	76.1 ± 118.96
Change from Baseline to Visit 23/Day 85	77.1 ± 119.08	78.0 ± 104.52

SecondaryChanges 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)

Time frame:: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 days
Reported as:: Mean · mIU/mL

Changes From Baseline in Luteinizing Hormone Levels
mIU/mL	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	4.988 ± 1.8540	5.272 ± 2.0365
Change from Baseline to Visit 3/Day 5	2.318 ± 3.1376	2.391 ± 2.3369
Change from Baseline to Visit 4/Day 8	3.647 ± 3.9407	2.855 ± 3.5869
Change from Baseline to Visit 5/Day 11	5.306 ± 4.5544	3.573 ± 3.3224
Change from Baseline to Visit 6/Day 15	4.011 ± 15.0705	1.759 ± 3.4399
Change from Baseline to Visit 7/Day 18	0.193 ± 4.0425	-0.024 ± 4.3170
Change from Baseline to Visit 8/Day 22	-0.625 ± 2.6920	-0.108 ± 4.0482
Change from Baseline to Visit 9/Day 25	-0.233 ± 2.5591	0.094 ± 3.6229
Change from Baseline to Visit 10/Day 29	0.071 ± 1.8310	0.597 ± 3.8260
Change from Baseline to Visit 12/Day 36	2.219 ± 4.3152	1.377 ± 3.3823
Change from Baseline to Visit 13/Day 43	1.143 ± 3.1123	1.915 ± 6.8802
Change from Baseline to Visit 14/Day 50	-0.146 ± 2.6963	0.918 ± 3.5897
Change from Baseline to Visit 15/Day 57	0.738 ± 3.6271	0.916 ± 3.7356
Change from Baseline to Visit 16/Day 64	2.835 ± 8.3480	2.622 ± 3.8875
Change from Baseline to Visit 17/Day 71	1.158 ± 3.3195	1.512 ± 4.0583
Change from Baseline to Visit 18/Day 78	0.302 ± 4.6718	1.335 ± 4.1741
Change from Baseline to Visit 23/Day 85	2.780 ± 8.988	1.416 ± 4.0763

SecondaryChanges 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

Time frame:: Days 0, 29, 57, 78, 85, up to 85 days
Reported as:: Mean · mIU/mL

Changes From Baseline in Follicle-Stimulating Hormone Levels
mIU/mL	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	6.588 ± 2.1862	6.626 ± 2.5115
Change from Baseline to Visit 10/Day 29	-0.928 ± 1.8646	-1.368 ± 2.2185
Change from Baseline to Visit 15/Day 57	-1.912 ± 2.6797	-1.858 ± 3.1649
Change from Baseline to Visit 18/Day 78	-2.190 ± 2.6875	-2.113 ± 3.0552
Change from Baseline to Visit 23/Day 85	-1.035 ± 2.4421	-2.003 ± 2.8092

SecondaryChanges 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

Time frame:: Days 0, 29, 57, 78, 85, up to 85 days
Reported as:: Mean · ug/mL

Changes From Baseline in Sex Hormone-Binding Globulin Levels
ug/mL	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	5.407 ± 2.5143	5.367 ± 2.3355
Change from Baseline to Visit 10/Day 29	-1.243 ± 1.2113	-1.737 ± 1.5096
Change from Baseline to Visit 15/Day 57	-1.032 ± 1.4994	-2.158 ± 1.5545
Change from Baseline to Visit 18/Day 78	-1.091 ± 1.3419	-2.203 ± 1.5719
Change from Baseline to Visit 23/Day 85	-0.585 ± 1.2964	-1.299 ± 1.4768

SecondaryOvarian 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)

Time frame:: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Reported as:: Mean · Number of Follicles

Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Number of Follicles	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	2.9 ± 2.59	2.9 ± 2.71
Visit 1/Day 1	2.5 ± 2.16	2.1 ± 1.77
Visit 3/Day 5	3.4 ± 2.71	3.8 ± 4.64
Visit 4/Day 8	3.2 ± 3.05	3.1 ± 3.03
Visit 5/Day 11	2.7 ± 1.91	2.4 ± 1.92
Visit 7/Day 18	1.9 ± 1.65	2.1 ± 2.05
Visit 8/Day 22	1.2 ± 1.31	2.4 ± 4.94
Visit 9/Day 25	1.6 ± 1.83	2.0 ± 2.03
Visit 10/Day 29	2.6 ± 2.47	2.0 ± 1.58
Visit 12/Day 36	2.7 ± 2.84	2.6 ± 2.35
Visit 13/Day 43	2.4 ± 2.23	2.1 ± 1.99
Visit 14/Day 50	1.6 ± 1.76	2.2 ± 1.71
Visit 15/Day 57	2.3 ± 2.14	2.9 ± 3.30
Visit 16/Day 64	2.6 ± 2.50	2.8 ± 2.84
Visit 17/Day 71	2.4 ± 2.13	2.3 ± 2.35
Visit 18/Day 78	2.1 ± 1.97	1.9 ± 1.96

SecondaryOvarian 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)

Time frame:: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Reported as:: Mean · mm

Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
mm	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	15.9 ± 6.00	16.1 ± 6.09
Visit 1/Day 1	9.9 ± 3.60	10.4 ± 5.27
Visit 3/Day 5	13.0 ± 4.08	12.9 ± 6.46
Visit 4/Day 8	16.0 ± 5.34	16.0 ± 7.35
Visit 5/Day 11	16.1 ± 7.13	17.4 ± 7.85
Visit 7/Day 18	15.1 ± 9.71	18.8 ± 11.76
Visit 8/Day 22	16.6 ± 11.64	17.3 ± 10.96
Visit 9/Day 25	15.0 ± 9.80	18.8 ± 12.82
Visit 10/Day 29	12.9 ± 8.51	17.0 ± 11.94
Visit 12/Day 36	16.0 ± 7.55	18.1 ± 11.34
Visit 13/Day 43	16.2 ± 9.35	18.5 ± 9.83
Visit 14/Day 50	16.1 ± 10.49	16.7 ± 8.23
Visit 15/Day 57	16.9 ± 11.06	14.5 ± 7.41
Visit 16/Day 64	18.3 ± 10.36	13.5 ± 6.80
Visit 17/Day 71	17.9 ± 11.60	16.5 ± 8.13
Visit 18/Day 78	16.7 ± 11.32	16.8 ± 9.58

SecondaryOvarian 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)

Time frame:: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Reported as:: Mean · mm

Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
mm	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Baseline	14.2 ± 5.7	14.5 ± 5.30
Visit 1/Day 1	8.7 ± 3.34	9.0 ± 4.90
Visit 3/Day 5	11.8 ± 3.85	11.6 ± 5.98
Visit 4/Day 8	14.4 ± 5.00	14.5 ± 6.54
Visit 5/Day 11	14.4 ± 6.21	15.4 ± 7.29
Visit 7/Day 18	13.7 ± 9.08	16.9 ± 10.68
Visit 8/Day 22	14.4 ± 9.82	15.6 ± 10.14
Visit 9/Day 25	12.8 ± 8.29	16.8 ± 11.92
Visit 10/Day 29	11.5 ± 7.57	15.4 ± 10.69
Visit 12/Day 36	14.4 ± 6.88	16.2 ± 9.99
Visit 13/Day 43	14.3 ± 8.83	16.8 ± 9.04
Visit 14/Day 50	14.5 ± 9.45	14.8 ± 7.56
Visit 15/Day 57	14.8 ± 9.87	13.1 ± 6.89
Visit 16/Day 64	16.6 ± 9.70	11.8 ± 5.88
Visit 17/Day 71	15.7 ± 10.55	14.9 ± 7.45
Visit 18/Day 78	14.7 ± 10.24	15.1 ± 8.73

SecondaryNumber 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

Time frame:: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks
Reported as:: Count of participants · Participants

Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Participants	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Weeks 1-4	14	15
Weeks 5-8	27	8
Weeks 9-11	16	7
Post-Treatment Week 12	18	10

SecondaryNumber 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

Time frame:: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks
Reported as:: Count of participants · Participants

Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Participants	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Weeks 1-4	29	9
Weeks 5-8	12	4
Weeks 9-11	12	6
Post-Treatment Week 12	7	5

SecondaryBleeding 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

Time frame:: Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12, up to 12 Weeks
Reported as:: Mean · Number of Days

Bleeding Patterns Based on Number of Bleeding/Spotting Days
Number of Days	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Weeks 1-4	7.5 ± 3.47	7.4 ± 3.73
Weeks 5-8	6.6 ± 4.53	9.4 ± 5.68
Weeks 9-11	5.1 ± 4.09	6.3 ± 4.71
Post-Treatment Week 12	2.9 ± 4.27	2.1 ± 2.30

SecondaryPatch 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.

Time frame:: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days
Reported as:: Count of participants · Participants

Patch Wearability Based on Skin Irritation
Participants	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Visit 4/Day 8: None	55	47
Visit 4/Day 8: Mild	5	9
Visit 4/Day 8: Moderate	0	2
Visit 4/Day 8: Significant	0	0
Visit 6/Day 15: None	50	42
Visit 6/Day 15: Mild	7	13
Visit 6/Day 15: Moderate	1	1
Visit 6/Day 15: Significant	0	0
Visit 8/Day 22: None	53	45
Visit 8/Day 22: Mild	6	7
Visit 8/Day 22: Moderate	0	3
Visit 8/Day 22: Significant	0	0
Visit 10/Day 29: None	52	42
Visit 10/Day 29: Mild	5	9
Visit 10/Day 29: Moderate	1	3
Visit 10/Day 29: Significant	0	0
Visit 12/Day 36: None	53	38
Visit 12/Day 36: Mild	5	15
Visit 12/Day 36: Moderate	1	1
Visit 12/Day 36: Significant	0	0
Visit 13/Day 43: None	48	37
Visit 13/Day 43: Mild	8	14
Visit 13/Day 43: Moderate	1	1
Visit 13/Day 43: Significant	0	0
Visit 14/Day 50: None	53	39
Visit 14/Day 50: Mild	2	10
Visit 14/Day 50: Moderate	2	1
Visit 14/Day 50: Significant	0	0
Visit 15/Day 57: None	50	36
Visit 15/Day 57: Mild	6	10
Visit 15/Day 57: Moderate	1	3
Visit 15/Day 57: Significant	0	0
Visit 16/Day 64: None	45	39
Visit 16/Day 64: Mild	11	8
Visit 16/Day 64: Moderate	0	2
Visit 16/Day 64: Significant	0	0
Visit 17/Day 71: None	51	39
Visit 17/Day 71: Mild	4	6
Visit 17/Day 71: Moderate	2	3
Visit 17/Day 71: Significant	0	1
Visit 18/Day 78: None	53	40
Visit 18/Day 78: Mild	3	6
Visit 18/Day 78: Moderate	0	1
Visit 18/Day 78: Significant	0	1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dose Level AG1000-6.5	0/61 (0%)	0/61 (0%)	53/61 (86.9%)
Dose Level AG1000-12.5	0/60 (0%)	1/60 (1.7%)	58/60 (96.7%)

Most frequent serious events

Most frequent serious events
Event	Dose Level AG1000-6.5	Dose Level AG1000-12.5
Retinal Vein OcclusionEye disorders	0/61	1/60

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Dose Level AG1000-6.5	Dose Level AG1000-12.5
HeadacheNervous system disorders	19/61	24/60
Application site irritationGeneral disorders	12/61	21/60
Skin irritationSkin and subcutaneous tissue disorders	16/61	20/60
Vaginal haemorrhageReproductive system and breast disorders	7/61	10/60
Upper respiratory tract infectionInfections and infestations	7/61	8/60
Menstruation irregularReproductive system and breast disorders	5/61	7/60
NasopharyngitisInfections and infestations	4/61	6/60
Breast tendernessReproductive system and breast disorders	6/61	3/60
NauseaGastrointestinal disorders	5/61	5/60
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	5/61	1/60

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Dose Level AG1000-6.5	Dose Level AG1000-12.5	Total
<=18 years	0	0	0
Between 18 and 65 years	61	60	121
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Dose Level AG1000-6.5	Dose Level AG1000-12.5	Total
Mean	30.9 ± 5.92	31.0 ± 7.22	30.9 ± 6.57

Sex: Female, Male
Sex: Female, Male(Participants)	Dose Level AG1000-6.5	Dose Level AG1000-12.5	Total
Female	61	60	121
Male	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Dose Level AG1000-6.5	Dose Level AG1000-12.5	Total
United States	61	60	121

Study locations

6 sites

University of Colorado - Adv. Repro. Med.
Aurora, Colorado 80045, United States
Columbia University
New York, New York 10032, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267, United States
Oregon Health Sciences University
Portland, Oregon 97239, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania 15213, United States

Registry details

Key details

Study ID: NCT01166412
Lead sponsor: Premier Research
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Sponsor
First posted: Jul 21, 2010
Start date: Dec 2010
Primary completion: Jul 2012
Completion: Jul 2012
Results posted: Jan 7, 2026
Last update: Jan 7, 2026

Oversight

Data monitoring committee: Yes

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