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

July 2, 2018 updated by: Agile Therapeutics

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1504

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Agile Investigational Site
      • Mobile, Alabama, United States, 36608
        • Agile Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Agile Investigational Site
      • Green Valley, Arizona, United States, 85614
        • Agile Investigational Site
      • Tucson, Arizona, United States, 85712
        • Agile Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Agile Investigational Site
    • California
      • La Mesa, California, United States, 91942
        • Agile Investigational Site
      • Los Angeles, California, United States, 90057
        • Agile Investigational Site
      • Sacramento, California, United States, 95831
        • Agile Investigational
      • San Diego, California, United States, 92103
        • Agile Investigational Site
      • Santa Ana, California, United States, 92705
        • Agile Investigational Site
      • Vista, California, United States, 92083
        • Agile Investigational Site
      • West Hills, California, United States, 91307
        • Agile Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80302
        • Agile Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • Agile Investigational Site
      • Denver, Colorado, United States, 80207
        • Agile Investigational Site
      • Fort Collins, Colorado, United States, 80524
        • Agile Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Agile Investigational Site
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Agile Investigational Site
      • New London, Connecticut, United States, 06320
        • Agile Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Agile Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Agile Investigational Site
      • Clearwater, Florida, United States, 33759
        • Agile Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • Agile Investigational Site
      • DeLand, Florida, United States, 32720
        • Agile Investigational Site
      • Fort Myers, Florida, United States, 33916
        • Agile Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Agile Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • Agile Investigational Site
      • Saint Petersburg, Florida, United States, 33709
        • Agile Investigational Site
      • South Miami, Florida, United States, 33143
        • Agile Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Agile Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Agile Investigational Site
      • Decatur, Georgia, United States, 30034
        • Agile Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • Agile Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Agile Investigational Site
      • Chicago, Illinois, United States, 60654
        • Agile Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Agile Investigational Site
      • Newburgh, Indiana, United States, 47630
        • Agile Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Agile Investigational Site
      • Wichita, Kansas, United States, 67205
        • Agile Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Agile Investigational Site
      • Louisville, Kentucky, United States, 40291
        • Agile Investigational Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Agile Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Agile Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Agile Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08817
        • Agile Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Agile Investigational Site
    • New York
      • Rochester, New York, United States, 14609
        • Agile Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Agile Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Agile Investigational Site
      • Kernersville, North Carolina, United States, 27284
        • Agile Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Agile Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Agile Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Agile Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Agile Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Agile Investigational Site
      • Cincinnati, Ohio, United States, 45267
        • Agile Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Agile Investigational Site
      • Columbus, Ohio, United States, 43213
        • Agile Investigational Site
      • Englewood, Ohio, United States, 45322
        • Agile Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Agile Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Agile Investigational Site
      • Tulsa, Oklahoma, United States, 74105
        • Agile Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Agile Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Agile Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Agile Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Agile Investigational Site
    • Texas
      • Austin, Texas, United States, 78702
        • Agile Investigational Site
      • Bedford, Texas, United States, 76022
        • Agile Investigational Site
      • Corpus Christi, Texas, United States, 78414
        • Agile Investigational Site
      • Dallas, Texas, United States, 75231
        • Agile Investigational Site
      • Houston, Texas, United States, 77089
        • Agile Investigational Site
      • San Antonio, Texas, United States, 78229
        • Agile Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Agile Investigational Site
      • Webster, Texas, United States, 77598
        • Agile Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Agile Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Agile Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Agile Investigational Site
      • Richmond, Virginia, United States, 23294
        • Agile Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Agile Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
Drug: AG200-15 (cycles 1-13)
AG200-15 containing ethinyl estradiol and levonorgestrel
Other Names:
  • transdermal patch
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.
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.
Other Names:
  • hormonal oral contraception and transdermal patch

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months
Self-reported Irritation at Application Site
Time Frame: 1 year

Evaluation of irritation at application site was determined using the following scores:

0: None

  1. Mild
  2. Moderate
  3. Severe
1 year
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)

  1. >= 75% adhered but < 90% (some edges showing lift)
  2. >= 50% adhered but < 75% (half of system lifts off)
  3. < 50% (> half of system lifts off, but undetached)
  4. patch completely detached
1 year
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

  1. Mild
  2. Moderate
  3. Severe
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agile Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ATI-CL12
  • 57731 (Other Identifier: FDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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