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

April 24, 2020 updated by: Agile Therapeutics

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2032

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AG200-15
AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)
Drug: AG200-15
Transdermal contraceptive delivery system
Other Names:
  • Transdermal contraceptive delivery system

What is the study measuring?

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Skin Irritation at Application Site
Time Frame: 1 year

Self-reported skin irritation at application site was assessed using the following scoring method:

0: None

  1. Mild
  2. Moderate
  3. Severe
1 year
Self-reported Skin Itching at Application Site
Time Frame: 1 year

Self-reported skin itching at application site was assessed using the following scoring method:

0: None

  1. Mild
  2. Moderate
  3. Severe
1 year
Self-reported Patch Adhesion
Time Frame: 1 year

Patch adhesion was reported using the following 5-point scoring method:

0: ≥ 90% adhered (none to minimal lift)

  1. ≥ 75% adhered but < 90% (some edges showing lift)
  2. ≥ 50% adhered but < 75% (at least half of system lifts off)
  3. < 50% (more than half of the patch lifts off, but the patch remains attached)
  4. Patch completely detached.
1 year
Cycle Control
Time Frame: 1 year
Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agile Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI-CL23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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