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Completed

NCT Number: NCT02158572

Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System

Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

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Key information

Conditions

Healthy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
  • Ability to demonstrate willingness to participate and adhere to study protocol

Exclusion criteria

  • Known or suspected pregnancy
  • Lactating women
  • Anticipates use of condoms or any other form of back-up contraception during the study
  • History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
  • Has a contraindication to combined estrogen-progestin contraceptive use
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Smoker who is 35 years old or over

Treatment and study plan

AG200-15

Drug

Transdermal contraceptive delivery system

Other names: Transdermal contraceptive delivery system

Primary outcomes

  1. Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.

    Time frame: 1 year

    The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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. Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset

    Time frame: 1 year

    Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 25 kg/m2, ITT dataset. 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.

  2. Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset

    Time frame: 1 year

    Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 25 and < 30 kg/m2, ITT dataset. 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.

  3. Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset

    Time frame: 1 year

    Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 30 kg/m2, ITT dataset. 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. Self-reported Skin Irritation at Application Site

    Time frame: 1 year

    Self-reported skin irritation at application site was assessed using the following scoring method:

    0: None

    • Mild
    • Moderate
    • Severe

  2. Self-reported Skin Itching at Application Site

    Time frame: 1 year

    Self-reported skin itching at application site was assessed using the following scoring method:

    0: None

    • Mild
    • Moderate
    • Severe

  3. Self-reported Patch Adhesion

    Time frame: 1 year

    Patch adhesion was reported using the following 5-point scoring method:

    0: ≥ 90% adhered (none to minimal lift)

    • ≥ 75% adhered but < 90% (some edges showing lift)
    • ≥ 50% adhered but < 75% (at least half of system lifts off)
    • < 50% (more than half of the patch lifts off, but the patch remains attached)
    • Patch completely detached.

  4. Cycle Control

    Time frame: 1 year

    Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.

Sponsors and collaborators

Lead sponsor

Agile Therapeutics

Industry

Registry information

Official study title

A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2014
Registry last updated
May 6, 2020

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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