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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: AG200-15

• Registration Number: NCT02158572
• Lead Sponsor: Agile Therapeutics

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Study Start: 2014-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-07-25
• Results First Submitted QC: 2017-08-25
• Results First Posted: 2017-09-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2032

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset	1 year	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.
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset	1 year	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.
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset	1 year	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.