AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol

Study Overview
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Brief Summary
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Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.

Detailed Description
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This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week). Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).

Official Title
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An Open-Label Study to Evaluate Pharmacokinetic Profile of Agile TCDS AG200-15 and to Compare Exposure to Ethinyl Estradiol to Oral Contraceptive (Orthocyclen®) in Healthy Female Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ortho-Cyclen
* Drug: AG200-15


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women, ages 18-45 Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs. Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period Exclusion Criteria: Known or suspected pregnancy; Lactating women Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) Use of other contraceptive methods than study medication Smokers

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ortho-Cyclen®<br>Ortho-Cyclen® is a comparator drug intervention | Drug: Ortho-Cyclen<br>* Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.<br>* Other names: oral contraceptive;|
| Experimental: AG200-15<br>AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention | Drug: AG200-15<br>* AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE<br>* Other names: transdermal contraception;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3. | 3 months | 
| Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. | 3 months | 
| Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. | 3 months | 
| Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. | 3 months | 
| Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured. | 3 months | 
| Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured. | 3 months | 
| Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | 3 months | 
| Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | 3 months | 
| Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval). | 3 months | 
| Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval). | 3 months | 
| Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 | Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3. | 3 months | 
| Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3 | Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3. | 3 months | 
| Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | 3 months | 

 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