Contraception
Conditions
Brief 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.
Interventions
DRUGlevonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2
6.5mg patch daily for 11 weeks
DRUGlevonorgestrel patch with BMI <32 kg/m2
6.5mg patch daily for 11 weeks
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Premier Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Poor Cervical Mucus Scores During Treatment Period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patch Wearability Based on Patch Adhesion | Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days | 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 |
| LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12), up to 78 days | 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. |
| Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Treatment Days 2, 8, 15, 22, 30, 36, 43, 50, 57, 64, 71, 79, 80, 81, 82, and 85, up to 85 days | 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) |
| Changes From Baseline in Estradiol Levels | 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 (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) |
| Changes From Baseline in Luteinizing Hormone Levels | 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 (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) |
| Changes From Baseline in Follicle-Stimulating Hormone Levels | Days 0, 29, 57, 78, 85, up to 85 days | 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 |
| Changes From Baseline in Sex Hormone-Binding Globulin Levels | Days 0, 29, 57, 78, 85, up to 85 days | 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 |
| Changes From Baseline in Endometrial Thickness | Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days | 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) |
| Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days | 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) |
| Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days | 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) |
| Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks | 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 |
| Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeks | 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 |
| Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12, up to 12 Weeks | 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 |
| Patch Wearability Based on Skin Irritation | Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days | 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. |
| Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 days | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose Level AG1000-6.5 levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks | 61 |
| Dose Level AG1000-12.5 levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks | 60 |
| Total | 121 |
Baseline characteristics
| Characteristic | Dose Level AG1000-12.5 | Dose Level AG1000-6.5 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 61 Participants | 121 Participants |
| Age, Continuous | 31.0 years STANDARD_DEVIATION 7.22 | 30.9 years STANDARD_DEVIATION 5.92 | 30.9 years STANDARD_DEVIATION 6.57 |
| Region of Enrollment United States | 60 participants | 61 participants | 121 participants |
| Sex: Female, Male Female | 60 Participants | 61 Participants | 121 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 60 |
| other Total, other adverse events | 53 / 61 | 58 / 60 |
| serious Total, serious adverse events | 0 / 61 | 1 / 60 |
Outcome results
Primary
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)
Population: Only cervical mucus data collected after the first dose of study drug is included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Level AG1000-6.5 | Number of Subjects With Poor Cervical Mucus Scores During Treatment Period | 3 Participants |
| Dose Level AG1000-12.5 | Number of Subjects With Poor Cervical Mucus Scores During Treatment Period | 11 Participants |
Secondary
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
Population: subjects that completed diaries during the specified timeframe
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 9-11 | 5.1 Number of Days | Standard Deviation 4.09 |
| Dose Level AG1000-6.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 5-8 | 6.6 Number of Days | Standard Deviation 4.53 |
| Dose Level AG1000-6.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Post-Treatment Week 12 | 2.9 Number of Days | Standard Deviation 4.27 |
| Dose Level AG1000-6.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 1-4 | 7.5 Number of Days | Standard Deviation 3.47 |
| Dose Level AG1000-12.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Post-Treatment Week 12 | 2.1 Number of Days | Standard Deviation 2.3 |
| Dose Level AG1000-12.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 5-8 | 9.4 Number of Days | Standard Deviation 5.68 |
| Dose Level AG1000-12.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 9-11 | 6.3 Number of Days | Standard Deviation 4.71 |
| Dose Level AG1000-12.5 | Bleeding Patterns Based on Number of Bleeding/Spotting Days | Weeks 1-4 | 7.4 Number of Days | Standard Deviation 3.73 |
Secondary
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
Population: Subjects that had endometrial thickness measured at the respective timepoints were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Baseline | 7.68 mm | Standard Deviation 3.243 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 1/Day 1 | -2.94 mm | Standard Deviation 3.885 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 3/Day 5 | -2.77 mm | Standard Deviation 3.377 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 4/Day 8 | -1.75 mm | Standard Deviation 3.706 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 5/Day 11 | -0.71 mm | Standard Deviation 3.239 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 7/Day 18 | -0.91 mm | Standard Deviation 4.367 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 8/Day 22 | -1.34 mm | Standard Deviation 3.96 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 9/Day 25 | -1.97 mm | Standard Deviation 3.834 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 10/Day 29 | -2.67 mm | Standard Deviation 3.234 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 12/Day 36 | -2.10 mm | Standard Deviation 3.995 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 13/Day 43 | -1.67 mm | Standard Deviation 3.837 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 14/Day 50 | -1.72 mm | Standard Deviation 4.422 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 15/Day 57 | -2.18 mm | Standard Deviation 3.94 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 16/Day 64 | -2.26 mm | Standard Deviation 3.676 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 17/Day 71 | -2.08 mm | Standard Deviation 4.175 |
| Dose Level AG1000-6.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 18/Day 78 | -1.95 mm | Standard Deviation 3.857 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 18/Day 78 | -2.84 mm | Standard Deviation 3.526 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Baseline | 7.90 mm | Standard Deviation 2.792 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 10/Day 29 | -3.26 mm | Standard Deviation 3.413 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 1/Day 1 | -3.32 mm | Standard Deviation 3.73 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 15/Day 57 | -3.80 mm | Standard Deviation 3.477 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 3/Day 5 | -3.15 mm | Standard Deviation 2.936 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 12/Day 36 | -3.16 mm | Standard Deviation 3.436 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 4/Day 8 | -2.00 mm | Standard Deviation 3.121 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 17/Day 71 | -3.56 mm | Standard Deviation 3.224 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 5/Day 11 | -2.50 mm | Standard Deviation 3.673 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 13/Day 43 | -3.18 mm | Standard Deviation 3.183 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 7/Day 18 | -2.16 mm | Standard Deviation 3.216 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 16/Day 64 | -3.39 mm | Standard Deviation 3.637 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 8/Day 22 | -2.69 mm | Standard Deviation 3.384 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 14/Day 50 | -3.24 mm | Standard Deviation 3.456 |
| Dose Level AG1000-12.5 | Changes From Baseline in Endometrial Thickness | Change from Baseline to Visit 9/Day 25 | -2.87 mm | Standard Deviation 3.769 |
Secondary
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
Population: subjects that had samples collected at the respective timepoints were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 3/Day 5 | 44.7 pg/mL | Standard Deviation 66.19 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 12/Day 36 | 101.6 pg/mL | Standard Deviation 150.53 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 7/Day 18 | 129.1 pg/mL | Standard Deviation 122.25 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 13/Day 43 | 113.4 pg/mL | Standard Deviation 173.71 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 5/Day 11 | 158.4 pg/mL | Standard Deviation 166.04 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 14/Day 50 | 85.7 pg/mL | Standard Deviation 118.49 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 8/Day 22 | 71.5 pg/mL | Standard Deviation 107.17 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 15/Day 57 | 76.4 pg/mL | Standard Deviation 135.9 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 4/Day 8 | 119.4 pg/mL | Standard Deviation 108.95 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 16/Day 64 | 94.5 pg/mL | Standard Deviation 165.6 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 9/Day 25 | 33.8 pg/mL | Standard Deviation 78.86 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 17/Day 71 | 82.6 pg/mL | Standard Deviation 114.9 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 6/Day 15 | 147.1 pg/mL | Standard Deviation 143.95 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 18/Day 78 | 73.2 pg/mL | Standard Deviation 101.43 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 10/Day 29 | 21.4 pg/mL | Standard Deviation 55.67 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 23/Day 85 | 77.1 pg/mL | Standard Deviation 119.08 |
| Dose Level AG1000-6.5 | Changes From Baseline in Estradiol Levels | Baseline | 44.1 pg/mL | Standard Deviation 16.61 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 23/Day 85 | 78.0 pg/mL | Standard Deviation 104.52 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Baseline | 47.2 pg/mL | Standard Deviation 48.4 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 3/Day 5 | 43.8 pg/mL | Standard Deviation 60.55 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 4/Day 8 | 103.2 pg/mL | Standard Deviation 138.77 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 5/Day 11 | 170.7 pg/mL | Standard Deviation 207.28 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 6/Day 15 | 191.9 pg/mL | Standard Deviation 249.75 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 7/Day 18 | 123.8 pg/mL | Standard Deviation 164.5 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 8/Day 22 | 76.6 pg/mL | Standard Deviation 120.61 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 9/Day 25 | 65.0 pg/mL | Standard Deviation 121.64 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 10/Day 29 | 37.8 pg/mL | Standard Deviation 98.5 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 12/Day 36 | 53.9 pg/mL | Standard Deviation 110.2 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 13/Day 43 | 98.6 pg/mL | Standard Deviation 172.48 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 14/Day 50 | 73.7 pg/mL | Standard Deviation 166.09 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 15/Day 57 | 40.1 pg/mL | Standard Deviation 117.25 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 16/Day 64 | 42.4 pg/mL | Standard Deviation 104.84 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 17/Day 71 | 51.3 pg/mL | Standard Deviation 99.92 |
| Dose Level AG1000-12.5 | Changes From Baseline in Estradiol Levels | Change from Baseline to Visit 18/Day 78 | 76.1 pg/mL | Standard Deviation 118.96 |
Secondary
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
Population: subjects that had samples collected at the respective timepoints were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 10/Day 29 | -0.928 mIU/mL | Standard Deviation 1.8646 |
| Dose Level AG1000-6.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 18/Day 78 | -2.190 mIU/mL | Standard Deviation 2.6875 |
| Dose Level AG1000-6.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 15/Day 57 | -1.912 mIU/mL | Standard Deviation 2.6797 |
| Dose Level AG1000-6.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 23/Day 85 | -1.035 mIU/mL | Standard Deviation 2.4421 |
| Dose Level AG1000-6.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Baseline | 6.588 mIU/mL | Standard Deviation 2.1862 |
| Dose Level AG1000-12.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 23/Day 85 | -2.003 mIU/mL | Standard Deviation 2.8092 |
| Dose Level AG1000-12.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Baseline | 6.626 mIU/mL | Standard Deviation 2.5115 |
| Dose Level AG1000-12.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 10/Day 29 | -1.368 mIU/mL | Standard Deviation 2.2185 |
| Dose Level AG1000-12.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 15/Day 57 | -1.858 mIU/mL | Standard Deviation 3.1649 |
| Dose Level AG1000-12.5 | Changes From Baseline in Follicle-Stimulating Hormone Levels | Change from Baseline to Visit 18/Day 78 | -2.113 mIU/mL | Standard Deviation 3.0552 |
Secondary
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
Population: subjects that had samples collected at the respective timepoints were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 3/Day 5 | 2.318 mIU/mL | Standard Deviation 3.1376 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 12/Day 36 | 2.219 mIU/mL | Standard Deviation 4.3152 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 7/Day 18 | 0.193 mIU/mL | Standard Deviation 4.0425 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 13/Day 43 | 1.143 mIU/mL | Standard Deviation 3.1123 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 5/Day 11 | 5.306 mIU/mL | Standard Deviation 4.5544 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 14/Day 50 | -0.146 mIU/mL | Standard Deviation 2.6963 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 8/Day 22 | -0.625 mIU/mL | Standard Deviation 2.692 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 15/Day 57 | 0.738 mIU/mL | Standard Deviation 3.6271 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 4/Day 8 | 3.647 mIU/mL | Standard Deviation 3.9407 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 16/Day 64 | 2.835 mIU/mL | Standard Deviation 8.348 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 9/Day 25 | -0.233 mIU/mL | Standard Deviation 2.5591 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 17/Day 71 | 1.158 mIU/mL | Standard Deviation 3.3195 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 6/Day 15 | 4.011 mIU/mL | Standard Deviation 15.0705 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 18/Day 78 | 0.302 mIU/mL | Standard Deviation 4.6718 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 10/Day 29 | 0.071 mIU/mL | Standard Deviation 1.831 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 23/Day 85 | 2.780 mIU/mL | Standard Deviation 8.988 |
| Dose Level AG1000-6.5 | Changes From Baseline in Luteinizing Hormone Levels | Baseline | 4.988 mIU/mL | Standard Deviation 1.854 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 23/Day 85 | 1.416 mIU/mL | Standard Deviation 4.0763 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Baseline | 5.272 mIU/mL | Standard Deviation 2.0365 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 3/Day 5 | 2.391 mIU/mL | Standard Deviation 2.3369 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 4/Day 8 | 2.855 mIU/mL | Standard Deviation 3.5869 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 5/Day 11 | 3.573 mIU/mL | Standard Deviation 3.3224 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 6/Day 15 | 1.759 mIU/mL | Standard Deviation 3.4399 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 7/Day 18 | -0.024 mIU/mL | Standard Deviation 4.317 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 8/Day 22 | -0.108 mIU/mL | Standard Deviation 4.0482 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 9/Day 25 | 0.094 mIU/mL | Standard Deviation 3.6229 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 10/Day 29 | 0.597 mIU/mL | Standard Deviation 3.826 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 12/Day 36 | 1.377 mIU/mL | Standard Deviation 3.3823 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 13/Day 43 | 1.915 mIU/mL | Standard Deviation 6.8802 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 14/Day 50 | 0.918 mIU/mL | Standard Deviation 3.5897 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 15/Day 57 | 0.916 mIU/mL | Standard Deviation 3.7356 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 16/Day 64 | 2.622 mIU/mL | Standard Deviation 3.8875 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 17/Day 71 | 1.512 mIU/mL | Standard Deviation 4.0583 |
| Dose Level AG1000-12.5 | Changes From Baseline in Luteinizing Hormone Levels | Change from Baseline to Visit 18/Day 78 | 1.335 mIU/mL | Standard Deviation 4.1741 |
Secondary
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
Population: subjects that had samples collected at the respective timepoints were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 10/Day 29 | -1.243 ug/mL | Standard Deviation 1.2113 |
| Dose Level AG1000-6.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 18/Day 78 | -1.091 ug/mL | Standard Deviation 1.3419 |
| Dose Level AG1000-6.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 15/Day 57 | -1.032 ug/mL | Standard Deviation 1.4994 |
| Dose Level AG1000-6.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 23/Day 85 | -0.585 ug/mL | Standard Deviation 1.2964 |
| Dose Level AG1000-6.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Baseline | 5.407 ug/mL | Standard Deviation 2.5143 |
| Dose Level AG1000-12.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 23/Day 85 | -1.299 ug/mL | Standard Deviation 1.4768 |
| Dose Level AG1000-12.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Baseline | 5.367 ug/mL | Standard Deviation 2.3355 |
| Dose Level AG1000-12.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 10/Day 29 | -1.737 ug/mL | Standard Deviation 1.5096 |
| Dose Level AG1000-12.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 15/Day 57 | -2.158 ug/mL | Standard Deviation 1.5545 |
| Dose Level AG1000-12.5 | Changes From Baseline in Sex Hormone-Binding Globulin Levels | Change from Baseline to Visit 18/Day 78 | -2.203 ug/mL | Standard Deviation 1.5719 |
Secondary
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
Population: subjects that had samples collected at the respective timeframes were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 1/Visit 1 | 322.6247 hr*pg/mL | Standard Deviation 141.24822 |
| Dose Level AG1000-6.5 | LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 29/Visit 5 | 1326.6995 hr*pg/mL | Standard Deviation 1663.88816 |
| Dose Level AG1000-6.5 | LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 78/Visit 12 | 945.0963 hr*pg/mL | Standard Deviation 590.16226 |
| Dose Level AG1000-12.5 | LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 1/Visit 1 | 401.3429 hr*pg/mL | Standard Deviation 200.31346 |
| Dose Level AG1000-12.5 | LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 29/Visit 5 | 1997.9708 hr*pg/mL | Standard Deviation 1626.87132 |
| Dose Level AG1000-12.5 | LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed | Day 78/Visit 12 | 1303.4188 hr*pg/mL | Standard Deviation 781.29795 |
Secondary
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
Population: Subjects that had serum progesterone measured during the respective weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Level AG1000-6.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 1-4 | 29 Participants |
| Dose Level AG1000-6.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 5-8 | 12 Participants |
| Dose Level AG1000-6.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 9-11 | 12 Participants |
| Dose Level AG1000-6.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Post-Treatment Week 12 | 7 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Post-Treatment Week 12 | 5 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 1-4 | 9 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 9-11 | 6 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL) | Weeks 5-8 | 4 Participants |
Secondary
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
Population: Subjects that had serum progesterone measured during the respective weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Level AG1000-6.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 1-4 | 14 Participants |
| Dose Level AG1000-6.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 5-8 | 27 Participants |
| Dose Level AG1000-6.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 9-11 | 16 Participants |
| Dose Level AG1000-6.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Post-Treatment Week 12 | 18 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Post-Treatment Week 12 | 10 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 1-4 | 15 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 9-11 | 7 Participants |
| Dose Level AG1000-12.5 | Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL) | Weeks 5-8 | 8 Participants |
Secondary
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
Population: Subjects that had follicles measured and counted were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Baseline | 14.2 mm | Standard Deviation 5.7 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 1/Day 1 | 8.7 mm | Standard Deviation 3.34 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 3/Day 5 | 11.8 mm | Standard Deviation 3.85 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 4/Day 8 | 14.4 mm | Standard Deviation 5 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 5/Day 11 | 14.4 mm | Standard Deviation 6.21 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 7/Day 18 | 13.7 mm | Standard Deviation 9.08 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 8/Day 22 | 14.4 mm | Standard Deviation 9.82 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 9/Day 25 | 12.8 mm | Standard Deviation 8.29 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 10/Day 29 | 11.5 mm | Standard Deviation 7.57 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 12/Day 36 | 14.4 mm | Standard Deviation 6.88 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 13/Day 43 | 14.3 mm | Standard Deviation 8.83 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 14/Day 50 | 14.5 mm | Standard Deviation 9.45 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 15/Day 57 | 14.8 mm | Standard Deviation 9.87 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 16/Day 64 | 16.6 mm | Standard Deviation 9.7 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 17/Day 71 | 15.7 mm | Standard Deviation 10.55 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 18/Day 78 | 14.7 mm | Standard Deviation 10.24 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 18/Day 78 | 15.1 mm | Standard Deviation 8.73 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Baseline | 14.5 mm | Standard Deviation 5.3 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 10/Day 29 | 15.4 mm | Standard Deviation 10.69 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 1/Day 1 | 9.0 mm | Standard Deviation 4.9 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 15/Day 57 | 13.1 mm | Standard Deviation 6.89 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 3/Day 5 | 11.6 mm | Standard Deviation 5.98 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 12/Day 36 | 16.2 mm | Standard Deviation 9.99 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 4/Day 8 | 14.5 mm | Standard Deviation 6.54 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 17/Day 71 | 14.9 mm | Standard Deviation 7.45 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 5/Day 11 | 15.4 mm | Standard Deviation 7.29 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 13/Day 43 | 16.8 mm | Standard Deviation 9.04 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 7/Day 18 | 16.9 mm | Standard Deviation 10.68 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 16/Day 64 | 11.8 mm | Standard Deviation 5.88 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 8/Day 22 | 15.6 mm | Standard Deviation 10.14 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 14/Day 50 | 14.8 mm | Standard Deviation 7.56 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle | Visit 9/Day 25 | 16.8 mm | Standard Deviation 11.92 |
Secondary
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
Population: Subjects that had follicles measured and counted were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Baseline | 15.9 mm | Standard Deviation 6 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 1/Day 1 | 9.9 mm | Standard Deviation 3.6 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 3/Day 5 | 13.0 mm | Standard Deviation 4.08 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 4/Day 8 | 16.0 mm | Standard Deviation 5.34 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 5/Day 11 | 16.1 mm | Standard Deviation 7.13 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 7/Day 18 | 15.1 mm | Standard Deviation 9.71 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 8/Day 22 | 16.6 mm | Standard Deviation 11.64 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 9/Day 25 | 15.0 mm | Standard Deviation 9.8 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 10/Day 29 | 12.9 mm | Standard Deviation 8.51 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 12/Day 36 | 16.0 mm | Standard Deviation 7.55 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 13/Day 43 | 16.2 mm | Standard Deviation 9.35 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 14/Day 50 | 16.1 mm | Standard Deviation 10.49 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 15/Day 57 | 16.9 mm | Standard Deviation 11.06 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 16/Day 64 | 18.3 mm | Standard Deviation 10.36 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 17/Day 71 | 17.9 mm | Standard Deviation 11.6 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 18/Day 78 | 16.7 mm | Standard Deviation 11.32 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 18/Day 78 | 16.8 mm | Standard Deviation 9.58 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Baseline | 16.1 mm | Standard Deviation 6.09 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 10/Day 29 | 17.0 mm | Standard Deviation 11.94 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 1/Day 1 | 10.4 mm | Standard Deviation 5.27 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 15/Day 57 | 14.5 mm | Standard Deviation 7.41 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 3/Day 5 | 12.9 mm | Standard Deviation 6.46 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 12/Day 36 | 18.1 mm | Standard Deviation 11.34 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 4/Day 8 | 16.0 mm | Standard Deviation 7.35 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 17/Day 71 | 16.5 mm | Standard Deviation 8.13 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 5/Day 11 | 17.4 mm | Standard Deviation 7.85 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 13/Day 43 | 18.5 mm | Standard Deviation 9.83 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 7/Day 18 | 18.8 mm | Standard Deviation 11.76 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 16/Day 64 | 13.5 mm | Standard Deviation 6.8 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 8/Day 22 | 17.3 mm | Standard Deviation 10.96 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 14/Day 50 | 16.7 mm | Standard Deviation 8.23 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle | Visit 9/Day 25 | 18.8 mm | Standard Deviation 12.82 |
Secondary
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
Population: Subjects that had follicles measured and counted were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Baseline | 2.9 Number of Follicles | Standard Deviation 2.59 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 1/Day 1 | 2.5 Number of Follicles | Standard Deviation 2.16 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 3/Day 5 | 3.4 Number of Follicles | Standard Deviation 2.71 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 4/Day 8 | 3.2 Number of Follicles | Standard Deviation 3.05 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 5/Day 11 | 2.7 Number of Follicles | Standard Deviation 1.91 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 7/Day 18 | 1.9 Number of Follicles | Standard Deviation 1.65 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 8/Day 22 | 1.2 Number of Follicles | Standard Deviation 1.31 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 9/Day 25 | 1.6 Number of Follicles | Standard Deviation 1.83 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 10/Day 29 | 2.6 Number of Follicles | Standard Deviation 2.47 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 12/Day 36 | 2.7 Number of Follicles | Standard Deviation 2.84 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 13/Day 43 | 2.4 Number of Follicles | Standard Deviation 2.23 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 14/Day 50 | 1.6 Number of Follicles | Standard Deviation 1.76 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 15/Day 57 | 2.3 Number of Follicles | Standard Deviation 2.14 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 16/Day 64 | 2.6 Number of Follicles | Standard Deviation 2.5 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 17/Day 71 | 2.4 Number of Follicles | Standard Deviation 2.13 |
| Dose Level AG1000-6.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 18/Day 78 | 2.1 Number of Follicles | Standard Deviation 1.97 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 18/Day 78 | 1.9 Number of Follicles | Standard Deviation 1.96 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Baseline | 2.9 Number of Follicles | Standard Deviation 2.71 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 10/Day 29 | 2.0 Number of Follicles | Standard Deviation 1.58 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 1/Day 1 | 2.1 Number of Follicles | Standard Deviation 1.77 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 15/Day 57 | 2.9 Number of Follicles | Standard Deviation 3.3 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 3/Day 5 | 3.8 Number of Follicles | Standard Deviation 4.64 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 12/Day 36 | 2.6 Number of Follicles | Standard Deviation 2.35 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 4/Day 8 | 3.1 Number of Follicles | Standard Deviation 3.03 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 17/Day 71 | 2.3 Number of Follicles | Standard Deviation 2.35 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 5/Day 11 | 2.4 Number of Follicles | Standard Deviation 1.92 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 13/Day 43 | 2.1 Number of Follicles | Standard Deviation 1.99 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 7/Day 18 | 2.1 Number of Follicles | Standard Deviation 2.05 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 16/Day 64 | 2.8 Number of Follicles | Standard Deviation 2.84 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 8/Day 22 | 2.4 Number of Follicles | Standard Deviation 4.94 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 14/Day 50 | 2.2 Number of Follicles | Standard Deviation 1.71 |
| Dose Level AG1000-12.5 | Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm | Visit 9/Day 25 | 2.0 Number of Follicles | Standard Deviation 2.03 |
Secondary
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
Population: subjects that had patch adhesion assessed during the respective timepoints are included
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: Patch Off | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: >90% | 55 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: >90% | 56 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: 75-90% | 2 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: 50-75% | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: 75-90% | 2 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: >90% | 51 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: Patch Off | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: 75-90% | 5 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: Patch Off | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: 75-90% | 9 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: >90% | 51 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: >90% | 53 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: 75-90% | 5 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: >90% | 54 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: 75-90% | 4 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: >90% | 52 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: >90% | 54 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: 75-90% | 4 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: 75-90% | 3 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: >90% | 49 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: Patch Off | 2 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: >90% | 53 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: >90% | 51 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: 75-90% | 3 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: 75-90% | 6 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: 50-75% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: 75-90% | 6 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: <50% | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: Patch Off | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: Patch Off | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: >90% | 50 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: Patch Off | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: >90% | 46 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: 75-90% | 9 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: 50-75% | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 6/Day 15: Patch Off | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: >90% | 46 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: 75-90% | 7 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: <50% | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 8/Day 22: Patch Off | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: >90% | 44 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: 75-90% | 8 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: 50-75% | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 10/Day 29: Patch Off | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: >90% | 47 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: 75-90% | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: 50-75% | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 12/Day 36: Patch Off | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: >90% | 46 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: 75-90% | 4 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: 50-75% | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 13/Day 43: Patch Off | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: >90% | 42 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: 75-90% | 8 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 14/Day 50: Patch Off | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: >90% | 44 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: 75-90% | 4 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 15/Day 57: Patch Off | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: >90% | 43 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: 75-90% | 4 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 16/Day 64: Patch Off | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: >90% | 45 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: 75-90% | 4 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 17/Day 71: Patch Off | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: >90% | 40 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: 75-90% | 5 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: 50-75% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 18/Day 78: <50% | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Patch Adhesion | Visit 4/Day 8: 75-90% | 7 Participants |
Secondary
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
Population: subjects that had patch site skin irritation assessed during the respective timepoints are included
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: Moderate | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: Moderate | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: None | 52 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: None | 53 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: Moderate | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: Mild | 2 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: Mild | 5 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: Moderate | 2 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: Moderate | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: None | 50 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: None | 50 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: Mild | 6 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: Moderate | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: None | 53 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: None | 53 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: None | 45 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: Mild | 5 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: Mild | 11 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: Mild | 5 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: Moderate | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: Mild | 6 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: Moderate | 1 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: None | 51 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: Mild | 7 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: Mild | 4 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: Moderate | 2 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: Moderate | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: None | 48 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: None | 53 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: Mild | 3 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: Mild | 8 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: Moderate | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: Significant | 0 Participants |
| Dose Level AG1000-6.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: None | 55 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: Significant | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: None | 47 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: Mild | 9 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: Moderate | 2 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 4/Day 8: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: None | 42 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: Mild | 13 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: Moderate | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 6/Day 15: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: None | 45 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: Mild | 7 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: Moderate | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 8/Day 22: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: None | 42 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: Mild | 9 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: Moderate | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 10/Day 29: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: None | 38 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: Mild | 15 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: Moderate | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 12/Day 36: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: None | 37 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: Mild | 14 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: Moderate | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 13/Day 43: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: None | 39 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: Mild | 10 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: Moderate | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 14/Day 50: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: None | 36 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: Mild | 10 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: Moderate | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 15/Day 57: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: None | 39 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: Mild | 8 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: Moderate | 2 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 16/Day 64: Significant | 0 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: None | 39 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: Mild | 6 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: Moderate | 3 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 17/Day 71: Significant | 1 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: None | 40 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: Mild | 6 Participants |
| Dose Level AG1000-12.5 | Patch Wearability Based on Skin Irritation | Visit 18/Day 78: Moderate | 1 Participants |
Secondary
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
Population: subjects that had samples collected during the respective timepoints were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 2 | 181.489 ng/mL | Standard Deviation 174.4023 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 8 | 183.140 ng/mL | Standard Deviation 143.5979 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 15 | 175.092 ng/mL | Standard Deviation 123.098 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 22 | 174.769 ng/mL | Standard Deviation 126.9624 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 30 | 276.579 ng/mL | Standard Deviation 247.427 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 36 | 178.315 ng/mL | Standard Deviation 135.2644 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 43 | 168.591 ng/mL | Standard Deviation 136.0588 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 50 | 174.454 ng/mL | Standard Deviation 143.7253 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 57 | 176.129 ng/mL | Standard Deviation 133.7951 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 64 | 162.538 ng/mL | Standard Deviation 130.8442 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 71 | 167.253 ng/mL | Standard Deviation 128.7246 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 79 | 100.182 ng/mL | Standard Deviation 54.7594 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 80 | 72.311 ng/mL | Standard Deviation 41.8869 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 81 | 48.481 ng/mL | Standard Deviation 22.9973 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 82 | 37.506 ng/mL | Standard Deviation 22.2807 |
| Dose Level AG1000-6.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 85 | 29.554 ng/mL | Standard Deviation 25.5765 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 85 | 38.882 ng/mL | Standard Deviation 38.1462 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 2 | 392.703 ng/mL | Standard Deviation 354.6305 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 57 | 272.921 ng/mL | Standard Deviation 171.9373 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 8 | 301.107 ng/mL | Standard Deviation 181.3892 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 80 | 87.295 ng/mL | Standard Deviation 53.3175 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 15 | 290.184 ng/mL | Standard Deviation 212.5369 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 64 | 276.387 ng/mL | Standard Deviation 198.0998 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 22 | 349.906 ng/mL | Standard Deviation 259.7689 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 82 | 49.627 ng/mL | Standard Deviation 25.1602 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 30 | 519.327 ng/mL | Standard Deviation 398.7602 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 71 | 280.677 ng/mL | Standard Deviation 177.6261 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 36 | 309.459 ng/mL | Standard Deviation 320.7415 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 81 | 66.773 ng/mL | Standard Deviation 37.6578 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 43 | 301.725 ng/mL | Standard Deviation 218.2762 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 79 | 129.584 ng/mL | Standard Deviation 76.113 |
| Dose Level AG1000-12.5 | Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment. | Day 50 | 330.625 ng/mL | Standard Deviation 282.0871 |