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Completed

NCT Number: NCT01236768

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

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

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mobile, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

AG200-15

Drug

Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.

Other names: Transdermal contraceptive delivery system (TCDS)

Levora

Drug

One tablet of Levora will be taken each day for a 28 day cycle.

Other names: Hormonal oral contraceptive

Primary outcomes

  1. 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.

Secondary outcomes

  1. Safety

    Time frame: 6 months

    Adverse events

Other outcomes

  1. 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.

  2. Irritation and Itching at Application Site

    Time frame: 6 months

    AG200-15 irritation and itching scores are defined as follows:

    0=none

    • mild
    • moderate
    • severe

  3. Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)

    Time frame: 3 months and 6 months

    Measurement of plasma levels of levonorgestrel and ethinyl estradiol.

  4. Adhesion at Application Site

    Time frame: 6 months

    Measurement of adhesion of application site is defined as follows:

    0: >=90% adhered (no lifting)

    • >=75% adhered but <90% (some edges showing lifting)
    • >=50% adhered but <75% (half of the patch lifts off)
    • <50% (> half of patch lifts off, but not detached)
    • patch completely detached

Sponsors and collaborators

Lead sponsor

Agile Therapeutics

Industry

Registry information

Official study title

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

Acronym: ATI-CL13

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2010
Registry last updated
Sep 15, 2017

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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