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Completed

NCT Number: NCT01181479

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

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.

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Key information

Conditions

Contraception

Age range

17 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Agile Investigational Site, Huntsville, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AG200-15 (cycles 1-13)

Drug

AG200-15 containing ethinyl estradiol and levonorgestrel

Other names: transdermal patch

Lessina crossover to AG200-15

Drug

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 names: hormonal oral contraception and transdermal patch

Primary outcomes

  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 outcomes

  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

    • Mild
    • Moderate
    • 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)

    • >= 75% adhered but < 90% (some edges showing lift)
    • >= 50% adhered but < 75% (half of system lifts off)
    • < 50% (> half of system lifts off, but undetached)
    • 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

    • Mild
    • Moderate
    • Severe

Sponsors and collaborators

Lead sponsor

Agile Therapeutics

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 13, 2010
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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