Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System

Study Overview
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Brief Summary
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Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

Detailed Description
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AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week patch-free period.

Official Title
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A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)

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, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year Ability to demonstrate willingness to participate and adhere to study protocol Exclusion Criteria: Known or suspected pregnancy Lactating women Anticipates use of condoms or any other form of back-up contraception during the study History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc. Has a contraindication to combined estrogen-progestin contraceptive use Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) Smoker who is 35 years old or over
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AG200-15<br>AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) | Drug: AG200-15<br>* Transdermal contraceptive delivery system<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 |
| --- | --- | --- |
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. | The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 25 kg/m2, ITT dataset. 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. | 1 year | 
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 25 and < 30 kg/m2, ITT dataset. 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. | 1 year | 
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 30 kg/m2, ITT dataset. 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention of pregnancy