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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

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).

Interventions

  • Drug: AG200-15 (cycles 1-13)
    • AG200-15 containing ethinyl estradiol and levonorgestrel
  • 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.

Arms, Groups and Cohorts

  • Experimental: AG200-15 (cycles 1-13)
    • AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 17 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Agile Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elizabeth Garner, MD, MPH, Study Director, Agile Therapeutics

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