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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01236768
First received: November 5, 2010
Last updated: August 17, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Contraception Drug: AG200-15 Drug: Levora Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Safety [ Time Frame: 6 months ]
    Adverse events


Other Outcome Measures:
  • 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.

  • 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

  • Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) [ Time Frame: 3 months and 6 months ]
    Measurement of plasma levels of levonorgestrel and ethinyl estradiol.

  • 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


Enrollment: 407
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Hormonal oral contraceptive

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).
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236768

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

Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01236768     History of Changes
Other Study ID Numbers: ATI-CL13
Study First Received: November 5, 2010
Results First Received: July 20, 2017
Last Updated: August 17, 2017

Keywords provided by Agile Therapeutics:
Contraceptive

Additional relevant MeSH terms:
Contraceptive Agents
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Contraceptives, Oral, Hormonal
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on September 21, 2017