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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2032 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-11-30

Brief Summary

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AG200-15

AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)

Group Type EXPERIMENTAL

AG200-15

Intervention Type DRUG

Transdermal contraceptive delivery system

Interventions

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AG200-15

Transdermal contraceptive delivery system

Intervention Type DRUG

Other Intervention Names

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Transdermal contraceptive delivery system

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes