Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Detailed Description
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Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Official Title
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An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE

Conditions
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Contraception

Intervention / Treatment
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* Drug: AG200-15
* Drug: Levora


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sexually active women requesting contraception Regular menses every 24 - 35 days In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AG200-15<br>Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) | Drug: AG200-15<br>* Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period.<br>* Other names: Transdermal contraceptive delivery system (TCDS);|
| Active Comparator: Levora<br>oral contraceptive containing 150mcg of LNG and 30mcg of EE | Drug: Levora<br>* One tablet of Levora will be taken each day for a 28 day cycle.<br>* Other names: Hormonal oral contraceptive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Reported as Pearl Index | Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraceptive