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Efficacy, Safety and Tolerability Study of Agile AG200-15 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: NCT02158572
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AG200-15 Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2032 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : August 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: AG200-15
AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)
Drug: AG200-15
Transdermal contraceptive delivery system
Other Name: Transdermal contraceptive delivery system




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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.

  2. Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, Per-Protocol-Instructions (PPI) Dataset [ Time Frame: 1 year ]

    Contraception efficacy measured by 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.

    PPI Efficacy Dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.

    Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)


  3. Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI , PPI [ Time Frame: 1 year ]

    Contraception efficacy measured by 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.

    PPI dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.

    Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)



Other Outcome Measures:
  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

    1. Mild
    2. Moderate
    3. 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

    1. Mild
    2. Moderate
    3. 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)

    1. ≥ 75% adhered but < 90% (some edges showing lift)
    2. ≥ 50% adhered but < 75% (at least half of system lifts off)
    3. < 50% (more than half of the patch lifts off, but the patch remains attached)
    4. Patch completely detached.

  4. Cycle Control [ Time Frame: 1 year ]
    Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02158572


Sponsors and Collaborators
Agile Therapeutics
Investigators
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Study Director: Elizabeth Garner, MD, MPH Agile Therapeutics

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Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT02158572    
Other Study ID Numbers: ATI-CL23
First Posted: June 9, 2014    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: August 2017
Keywords provided by Agile Therapeutics:
prevention of pregnancy
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs