Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm (ATI-CL13)

August 17, 2017 updated by: Agile Therapeutics

An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Green Valley, Arizona, United States, 85614
      • Tucson, Arizona, United States, 85712
    • California
      • Los Angeles, California, United States, 90036
      • Los Angeles, California, United States, 90057
      • West Hills, California, United States, 91307
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Saint Petersburg, Florida, United States, 33709
      • South Miami, Florida, United States, 33143
    • Indiana
      • Newburgh, Indiana, United States, 47630
    • Kentucky
      • Louisville, Kentucky, United States, 40291
    • Nevada
      • Las Vegas, Nevada, United States, 89109
      • Las Vegas, Nevada, United States, 89128
    • North Carolina
      • Kernersville, North Carolina, United States, 27284
    • Ohio
      • Englewood, Ohio, United States, 45322
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74105
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Texas
      • Corpus Christi, Texas, United States, 78414
      • Sugar Land, Texas, United States, 77479
    • Virginia
      • Newport News, Virginia, United States, 23606
      • Norfolk, Virginia, United States, 23502

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • sexually active women requesting contraception
  • Regular menses every 24 - 35 days
  • In good general health, confirmed by medical history, physical (including gynecologic examination adn 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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AG200-15
Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
Drug: AG200-15
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Other Names:
  • Transdermal contraceptive delivery system (TCDS)
ACTIVE_COMPARATOR: Levora
oral contraceptive containing 150mcg of LNG and 30mcg of EE
Drug: Levora
One tablet of Levora will be taken each day for a 28 day cycle.
Other Names:
  • Hormonal oral contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Reported as Pearl Index
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6 months
Adverse events
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycle Control
Time Frame: 6 months
The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.
6 months
Irritation and Itching at Application Site
Time Frame: 6 months

AG200-15 irritation and itching scores are defined as follows:

0=none

  1. mild
  2. moderate
  3. severe
6 months
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
Time Frame: 3 months and 6 months
Measurement of plasma levels of levonorgestrel and ethinyl estradiol.
3 months and 6 months
Adhesion at Application Site
Time Frame: 6 months

Measurement of adhesion of application site is defined as follows:

0: >=90% adhered (no lifting)

  1. >=75% adhered but <90% (some edges showing lifting)
  2. >=50% adhered but <75% (half of the patch lifts off)
  3. <50% (> half of patch lifts off, but not detached)
  4. patch completely detached
6 months

Collaborators and Investigators

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

Sponsor

Agile Therapeutics

Investigators

  • Study Director: Marie Foegh, MD, Agile Therapeutics

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

October 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI-CL13

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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