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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: January 28, 2013
Last verified: January 2013
History of Changes
  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: Study Drug AG200-15, Contraceptives, Hormonal
Drug: Levora, Contraceptives, Oral, Hormonal
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 (TCDS) in Comparison to an Oral Contraceptive Containing 150 Mcg Levonorgestrel And 30 Mcg Ethinyl Estradiol

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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: Study Drug AG200-15, Contraceptives, Hormonal
Contraception; TCDS is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Active Comparator: Levora
oral contraceptive containing 150mcg of LNG and 30mcg of EE
 Drug: Levora, Contraceptives, Oral, Hormonal
one tablet will be taken each day for a 28 day cycle.

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
Genders 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
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, 90057
Los Angeles, California, United States, 90036
West Hills, California, United States, 91307
United States, Florida
Boynton Beach, Florida, United States, 33472
South Miami, Florida, United States, 33143
St. Petersburg, Florida, United States, 33709
United States, Indiana
Newburgh, Indiana, United States, 47630
United States, Kentucky
Louisville, Kentucky, United States, 40291
United States, Nevada
Las Vegas, Nevada, United States, 89128
Las Vegas, Nevada, United States, 89109
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
Mt. 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

No publications provided

Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01236768     History of Changes
Other Study ID Numbers: ATI-CL13
Study First Received: November 5, 2010
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Agile Therapeutics:
Contraceptive

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Hormonal
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 23, 2013