Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females

Study Overview
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Brief Summary
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This is a pharmacokinetics and safety study over 3 weekly applications.

Detailed Description
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Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).

Official Title
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A Pharmacokinetic Study of the Agile TCDS AG200-15 Following Weekly Application to Three Anatomical Sites (Abdomen, Buttock and Upper Torso) in Healthy Female Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: AG200-15


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women, ages 18-45 years Body mass index 18 - 32, and weight ≥ 110 lbs. Willing to use a non-hormonal method of contraception if of childbearing potential, Or have already undergone previous bilateral tubal ligation or hysterectomy Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period Willing to give informed consent to participate in study Hemoglobin within normal range. Exclusion Criteria: Known or suspected pregnancy A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater Smoking Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic) Diabetes Mellitus History of headaches with focal neurological symptoms Current or history of clinically significant depression in the last year Acute or chronic hepatocellular disease with abnormal liver function History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdomen, Buttock, Upper Torso<br>Patch was placed on abdomen, buttock then the upper torso excluding breast. Intervention: AG200-15 patch | Drug: AG200-15<br>* 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.<br>* Other names: Transdermal contraceptive delivery system;|
| Experimental: Abdomen, Upper Torso, Buttock<br>Patch was placed on abdomen, upper torso excluding breast then the buttock. Intervention: AG200-15 patch | Drug: AG200-15<br>* 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.<br>* Other names: Transdermal contraceptive delivery system;|
| Experimental: Buttock, Abdomen, Upper Torso<br>Patch was placed on the buttock, abdomen, then the upper torso excluding breast. Intervention: AG200-15 patch | Drug: AG200-15<br>* 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.<br>* Other names: Transdermal contraceptive delivery system;|
| Experimental: Buttock, Upper Torso, Abdomen,<br>Patch was placed on the buttock, upper torso excluding breast then the abdomen Intervention: AG200-15 patch | Drug: AG200-15<br>* 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.<br>* Other names: Transdermal contraceptive delivery system;|
| Experimental: Upper Torso, Abdomen, Buttock<br>Patch was placed on the upper torso excluding breast, abdomen then buttock. Intervention: AG200-15 patch | Drug: AG200-15<br>* 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.<br>* Other names: Transdermal contraceptive delivery system;|
| Experimental: Upper Torso, Buttock, Abdomen<br>Patch was place on the upper torso excluding breast, buttock, then abdomen. Intervention: AG200-15 patch | Drug: AG200-15<br>* 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.<br>* Other names: Transdermal contraceptive delivery system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PK and safety, Pharmacokinetic profile (PK) and safety