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This is a pharmacokinetics and safety study over 3 weekly applications.
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdomen, Buttock, Upper Torso | Experimental | Patch was placed on abdomen, buttock then the upper torso excluding breast. Intervention: AG200-15 patch |
|
| Abdomen, Upper Torso, Buttock | Experimental | Patch was placed on abdomen, upper torso excluding breast then the buttock. Intervention: AG200-15 patch |
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| Buttock, Abdomen, Upper Torso | Experimental | Patch was placed on the buttock, abdomen, then the upper torso excluding breast. Intervention: AG200-15 patch |
|
| Buttock, Upper Torso, Abdomen, | Experimental | Patch was placed on the buttock, upper torso excluding breast then the abdomen Intervention: AG200-15 patch |
|
| Upper Torso, Abdomen, Buttock | Experimental | Patch was placed on the upper torso excluding breast, abdomen then buttock. Intervention: AG200-15 patch |
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| Upper Torso, Buttock, Abdomen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG200-15 | Drug | A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-State Concentration (Css) (48-168) Profile for LNG | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | 6 weeks |
| Steady-State Concentration (Css) (48-168) Profile for EE | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | 6 weeks |
| Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | 6 weeks |
| Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Garner, MD | Agile Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | 68502 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Lower Abdomen, Buttock, Upper Torso Excluding Breast | Subjects applied AG200-15 to Abdomen, Buttock, then Upper Torso excluding Breast |
| FG001 | Lower Abdomen, Upper Torso Excluding Breast, Buttock | Subjects applied AG200-15 to Abdomen, Upper Torso excluding Breast, then Buttock |
| FG002 | Buttock, Lower Abdomen, Upper Torso Excluding Breast | Subjects applied AG200-15 to Buttock, Abdomen, then Upper Torso excluding Breast |
| FG003 | Buttock, Upper Torso Excluding Breast, Lower Abdomen | Subjects applied AG200-15 to Buttock, Upper Torso excluding Breast, then Lower Abdomen. |
| FG004 | Upper Torso Excluding Breast, Lower Abdomen, Buttock | Subjects applied AG200-15 to Upper Torso excluding Breast, Lower Abdomen, then Buttock |
| FG005 | Upper Torso Excluding Breast, Buttock, Lower Abdomen | Subjects applied AG200-15 to Upper Torso excluding Breast, Buttock, then Lower Abdomen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | AG200-15 | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Steady-State Concentration (Css) (48-168) Profile for LNG | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | Primary PK population | Posted | Mean | Standard Deviation | pg/mL | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AG200-15 on Lower Abdomen | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Chiodo III, Senior Medical Director | Agile Therapeutics | 609-683-1880 | jachiodo@agiletherapeutics.com |
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| Experimental |
Patch was place on the upper torso excluding breast, buttock, then abdomen. Intervention: AG200-15 patch |
|
|
| Neptune City |
| New Jersey |
| 07753 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
| Primary | Steady-State Concentration (Css) (48-168) Profile for EE | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | Primary PK population | Posted | Mean | Standard Deviation | pg/mL | 6 weeks |
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | Primary PK population | Posted | Mean | Standard Deviation | ng*hr/mL | 6 weeks |
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE | Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch. | Primary PK population | Posted | Mean | Standard Deviation | ng*hr/mL | 6 weeks |
|
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 19 |
| 22 |
| EG001 | AG200-15 on Buttock | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. | 0 | 23 | 0 | 23 | 23 | 23 |
| EG002 | AG200-15 on Upper Torso Excluding Breast | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. | 0 | 23 | 0 | 23 | 21 | 23 |
| General disorders and adminstration site conditions | General disorders | Non-systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Vascular disorders | Vascular disorders | Non-systematic Assessment |
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Approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL15 study is required prior to publication submission.
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