Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
NCT ID: NCT00910637
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1502 participants
INTERVENTIONAL
2009-05-01
2010-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Arm 1
Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles
Interventions
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Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles
Eligibility Criteria
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Inclusion Criteria
* Normal cervical smear
* Maximum age for smokers is 35
* History of regular cyclic menstrual periods
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Glendale, Arizona, United States
Precision Trials
Phoenix, Arizona, United States
Visions Clinical Research - Tucson
Tucson, Arizona, United States
Carmichael, California, United States
Pacific Palisades, California, United States
Paramount, California, United States
Genesis Center for Clinical Research
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Torrance, California, United States
Denver, Colorado, United States
Littleton, Colorado, United States
New London, Connecticut, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Roswell, Georgia, United States
Research Associates
Boise, Idaho, United States
Rosemark Women Care Specialist
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Newburgh, Indiana, United States
South Bend, Indiana, United States
Marrero, Louisiana, United States
Boston, Massachusetts, United States
Chaska, Minnesota, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Office of Dr. R. Garn Mabey, MD
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
Moorestown, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
New Bern, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
York Clinical Consulting
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Columbia, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Women's Care Center, PLC
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Corpus Christi, Texas, United States
Practice Research Organization
Dallas, Texas, United States
Advances in Health, inc.
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
Norfolk, Virginia, United States
Women's Clinical Research Center
Seattle, Washington, United States
Countries
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Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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310802
Identifier Type: OTHER
Identifier Source: secondary_id
91555
Identifier Type: -
Identifier Source: org_study_id
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