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Trial record 4 of 25 for:    gestodene

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

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: NCT00910637
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : February 8, 2013
Sponsor:
Information provided by:
Bayer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: Gestodene/EE Patch (BAY86-5016) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1502 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : May 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Vital signs [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  2. Physical and gynecological examinations [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  3. Laboratory assessments [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  4. Adverse events (AE monitoring) [ Time Frame: 13 treatment cycles each consisting of 28 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT00910637


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35235
United States, Arizona
Glendale, Arizona, United States, 85304
Phoenix, Arizona, United States, 85032
Tucson, Arizona, United States, 85712
United States, California
Carmichael, California, United States, 95608
Pacific Palisades, California, United States, 90272
Paramount, California, United States, 90723
San Diego, California, United States, 92103
San Diego, California, United States, 92108
San Diego, California, United States, 92123
San Francisco, California, United States, 94806
Santa Ana, California, United States, 92705
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80218
Littleton, Colorado, United States, 80122
Littleton, Colorado, United States, 80123
United States, Connecticut
New London, Connecticut, United States, 06320
United States, Florida
Boynton Beach, Florida, United States, 33472-2952
Bradenton, Florida, United States, 34203
Gainesville, Florida, United States, 32607
Jacksonville, Florida, United States, 32207
Miami, Florida, United States, 33186
Pembroke Pines, Florida, United States, 33024
St. Petersburg, Florida, United States, 33709
West Palm Beach, Florida, United States, 33409
United States, Georgia
Atlanta, Georgia, United States, 30328
Decatur, Georgia, United States, 30034
Roswell, Georgia, United States, 30075
United States, Idaho
Boise, Idaho, United States, 83702
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Newburgh, Indiana, United States, 47630
South Bend, Indiana, United States, 46601
United States, Louisiana
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Minnesota
Chaska, Minnesota, United States, 55318
United States, Missouri
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, Nevada
Las Vegas, Nevada, United States, 89030
Las Vegas, Nevada, United States, 89106
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Lawrenceville, New Jersey, United States, 08648
Moorestown, New Jersey, United States, 08057
Morristown, New Jersey, United States, 07960
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
New York, New York, United States, 10032
United States, North Carolina
New Bern, North Carolina, United States, 28562
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45267-0457
Cleveland, Ohio, United States, 44122
Columbus, Ohio, United States, 43213
Wadsworth, Ohio, United States, 44281
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Eugene, Oregon, United States, 97401
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19114
Pittsburgh, Pennsylvania, United States, 15206
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Columbia, South Carolina, United States, 29201
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Knoxville, Tennessee, United States, 37920
Memphis, Tennessee, United States, 38119
Nashville, Tennessee, United States, 37203
Nashville, Tennessee, United States, 37205
United States, Texas
Corpus Christi, Texas, United States, 78414
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77030
Houston, Texas, United States, 77054
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle, Washington, United States, 98105
Spokane, Washington, United States, 99207
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00910637     History of Changes
Other Study ID Numbers: 91555
310802 ( Other Identifier: Company internal )
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by Bayer:
Pregnancy prevention
Female contraception
Patch
Additional relevant MeSH terms:
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Gestodene
Contraceptive Agents
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Progestins