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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236768
First Posted: November 9, 2010
Last Update Posted: September 15, 2017
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.
Information provided by (Responsible Party):
Agile Therapeutics
November 5, 2010
November 9, 2010
July 20, 2017
September 15, 2017
September 15, 2017
October 2010
June 2011   (Final data collection date for primary outcome measure)
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.
Pregnancy [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01236768 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 6 months ]
Adverse events
Not Provided
  • 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
Not Provided
 
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
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.
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).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Contraception
  • 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)
  • Drug: Levora
    One tablet of Levora will be taken each day for a 28 day cycle.
    Other Name: Hormonal oral contraceptive
  • Experimental: AG200-15
    Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
    Intervention: Drug: AG200-15
  • Active Comparator: Levora
    oral contraceptive containing 150mcg of LNG and 30mcg of EE
    Intervention: Drug: Levora
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
407
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01236768
ATI-CL13
No
Not Provided
Not Provided
Agile Therapeutics
Agile Therapeutics
Not Provided
Study Director: Marie Foegh, MD Agile Therapeutics
Agile Therapeutics
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP