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Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

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: NCT01181479
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
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 (cycles 1-13) Drug: Lessina crossover to AG200-15 Phase 3

Detailed Description:
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, 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 : 1504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
Study Start Date : August 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
 Drug: AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel
Other Name: transdermal patch
Active Comparator: Lessina crossover to AG200-15
Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
 Drug: Lessina crossover to AG200-15
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Other Name: hormonal oral contraception and transdermal patch


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy [ Time Frame: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year ]
    Pregnancy outcomes was determine by measuring Pearl index. 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.


Other Outcome Measures:
  1. Cycle Control [ Time Frame: 6 months ]
    Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.

  2. Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) [ Time Frame: Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months ]
    Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.

  3. Self-reported Irritation at Application Site [ Time Frame: 1 year ]

    Evaluation of irritation at application site was determined using the following scores:

    0: None

    1. Mild
    2. Moderate
    3. Severe

  4. Patch Adhesion by Investigator Evaluation at Each Visit [ Time Frame: 1 year ]

    Evaluation of patch adhesion was determined using the following scores:

    0: >= 90% adhered (no lift)

    1. >= 75% adhered but < 90% (some edges showing lift)
    2. >= 50% adhered but < 75% (half of system lifts off)
    3. < 50% (> half of system lifts off, but undetached)
    4. patch completely detached

  5. Self-reported Itching at Patch Application Site [ Time Frame: 1 year ]

    Evaluation of itching at patch application site was determined using the following scores:

    0: None

    1. Mild
    2. Moderate
    3. Severe


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy females

  • 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
  • Regular, consistent menstrual cycles between 25 and 35 days
  • Sexually active women requesting birth control
  • In good general health, confirmed by medical history, physical (including gynecologic) examination and 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): NCT01181479


Locations
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Sponsors and Collaborators
Agile Therapeutics
Investigators
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Study Director: Elizabeth Garner, MD, MPH Agile Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01181479    
Other Study ID Numbers: ATI-CL12
57731 ( Other Identifier: FDA )
First Posted: August 13, 2010    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agile Therapeutics:
Contraceptive
Additional relevant MeSH terms:
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Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
 Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs