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A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.
Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.
There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG200-15 location | Experimental | The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG200-15 | Drug | There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) | AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 |
| AUC(0-168) Profile of Ethinyl Estradiol (EE) | AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 of LNG | Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 |
| Css (48-168) Profile of EE | Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patch Adhesion | Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale: 0: >90% adhered (essentially no lift off of the skin)
Patches were assessed prior to patch removal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Garner, MD, MPH | Agile Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | 33014 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AG200-15 Condition (NDC) | The subject will wear AG200-15 for 7 days and be exposed to normal (N), dry sauna (D) then cold water (C)conditions |
| FG001 | AG200-15 Condition (CNW) | The subject will wear AG200-15 for 7 days and be exposed to cold water (C), normal (N) then whirlpool (W)conditions |
| FG002 | AG200-15 Condition (WTN) | The subject will wear AG200-15 for 7 days and be exposed to whirlpool (W), treadmill (T) then normal (N)conditions |
| FG003 | AG200-15 Condition (NCD) | The subject will wear AG200-15 for 7 days and be exposed to normal (N), cold water (C) then dry sauna (D)conditions |
| FG004 | AG200-15 Condition (DNT) | The subject will wear AG200-15 for 7 days and be exposed to dry sauna (D), normal (N) then treadmill (T)conditions |
| FG005 | AG200-15 Condition (TWN) | The subject will wear AG200-15 for 7 days and be exposed to treadmill (T), whirlpool (W) then normal (N) conditions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | AG200-15 Condition | The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna). |
| 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 | Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) | AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 |
|
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 Condition | The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna). |
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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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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
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| 6 weeks |
| 6 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | AUC(0-168) Profile of Ethinyl Estradiol (EE) | AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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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|
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| Primary | Steady-state Concentration (Css) (48-168) Profile of LNG | Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 |
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|
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| Primary | Css (48-168) Profile of EE | Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 |
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| Secondary | Patch Adhesion | Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale: 0: >90% adhered (essentially no lift off of the skin)
Patches were assessed prior to patch removal. | Safety population | Posted | Mean | Standard Deviation | Score | 6 weeks |
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| 0 |
| 24 |
| 0 |
| 24 |
| 23 |
| 24 |
| General disorders and administration site conditions | General disorders | Non-systematic Assessment |
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| Infections and infestations | Infections and infestations | Non-systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Nervous system disorders | Nervous system 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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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal 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-CL16 study is required prior to publication submission.
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