Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

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, 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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Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.

Conditions
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Contraception

Intervention / Treatment
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* Drug: AG200-15 (cycles 1-13)
* Drug: Lessina crossover to AG200-15


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy females 17(in states where the legal age of consent to receive contraceptives is 17)-40 years Regular, consistent menstrual cycles between 25 and 35 days Sexually active women requesting birth control In good general health, confirmed by medical history, physical (including gynecologic) examination and 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: 17 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 (cycles 1-13)<br>AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug. | Drug: AG200-15 (cycles 1-13)<br>* AG200-15 containing ethinyl estradiol and levonorgestrel<br>* Other names: transdermal patch;|
| Active Comparator: Lessina crossover to AG200-15<br>Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug. | Drug: Lessina crossover to AG200-15<br>* Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.<br>* Other names: hormonal oral contraception and transdermal patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Pregnancy outcomes was determine by measuring 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. | AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year | 

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