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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01236768
Recruitment Status : Completed
First Posted : November 9, 2010
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: AG200-15 Drug: Levora Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Safety [ Time Frame: 6 months ]
    Adverse events


Other Outcome Measures:
  1. 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.

  2. 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

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

  4. 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


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236768


Locations
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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
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Study Director: Marie Foegh, MD Agile Therapeutics
More Information
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Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01236768    
Other Study ID Numbers: ATI-CL13
First Posted: November 9, 2010    Key Record Dates
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: August 2017
Keywords provided by Agile Therapeutics:
Contraceptive
Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Hormonal
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents, Hormonal