Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

April 6, 2021 updated by: Bayer

Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

This study is examining a birth control patch for 13 cycles (1 year).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1502

Phase

  • 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
      • Birmingham, Alabama, United States, 35235
    • Arizona
      • Glendale, Arizona, United States, 85304
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research - Tucson
    • California
      • Carmichael, California, United States, 95608
      • Pacific Palisades, California, United States, 90272
      • Paramount, California, United States, 90723
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92103
        • Genesis Center for Clinical Research
      • Santa Ana, California, United States, 92705
      • Torrance, California, United States, 90502
    • Colorado
      • Denver, Colorado, United States, 80218
      • Littleton, Colorado, United States, 80122
    • Connecticut
      • New London, Connecticut, United States, 06320
    • Florida
      • Boynton Beach, Florida, United States, 33472-2952
        • Visions Clinical Research
      • Jacksonville, Florida, United States, 32207
      • Miami, Florida, United States, 33186
      • Pembroke Pines, Florida, United States, 33024
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
      • Decatur, Georgia, United States, 30034
      • Roswell, Georgia, United States, 30075
    • Idaho
      • Boise, Idaho, United States, 83702
        • Research Associates
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialist
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Newburgh, Indiana, United States, 47630
      • South Bend, Indiana, United States, 46601
    • Louisiana
      • Marrero, Louisiana, United States, 70072
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Minnesota
      • Chaska, Minnesota, United States, 55318
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Las Vegas, Nevada, United States, 89106
      • Las Vegas, Nevada, United States, 89030
      • Las Vegas, Nevada, United States, 89128
        • Office of Dr. R. Garn Mabey, MD
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
      • Moorestown, New Jersey, United States, 08057
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • New York, New York, United States, 10032
    • North Carolina
      • New Bern, North Carolina, United States, 28562
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0457
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43213
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • York Clinical Consulting
    • Oregon
      • Eugene, Oregon, United States, 97401
      • Portland, Oregon, United States, 97239-3011
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15213
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Columbia, South Carolina, United States, 29201
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Knoxville, Tennessee, United States, 37920
      • Memphis, Tennessee, United States, 38119
        • Women's Care Center, PLC
      • Nashville, Tennessee, United States, 37203
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Corpus Christi, Texas, United States, 78414
      • Dallas, Texas, United States, 75230
        • Practice Research Organization
      • Houston, Texas, United States, 77054
        • The Woman's Hospital of Texas
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc.
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Center

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

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Requiring contraception
  • Normal cervical smear
  • Maximum age for smokers is 35
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of pregnancy (yes/no) while on treatment
Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
13 treatment cycles each consisting of 28 days and follow-up period of 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs
Time Frame: 13 treatment cycles each consisting of 28 days
13 treatment cycles each consisting of 28 days
Physical and gynecological examinations
Time Frame: 13 treatment cycles each consisting of 28 days
13 treatment cycles each consisting of 28 days
Laboratory assessments
Time Frame: 13 treatment cycles each consisting of 28 days
13 treatment cycles each consisting of 28 days
Adverse events (AE monitoring)
Time Frame: 13 treatment cycles each consisting of 28 days
13 treatment cycles each consisting of 28 days

Collaborators and Investigators

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

Sponsor

Bayer

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.

Helpful Links

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 (Actual)

May 1, 2009

Primary Completion (Actual)

December 13, 2010

Study Completion (Actual)

December 13, 2010

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91555
  • 310802 (Other Identifier: Company internal)

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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