Transdermal Contraceptive Patch - Endometrial Effects Study
NCT ID: NCT00896571
Last Updated: 2014-11-26
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
PHASE2
92 participants
INTERVENTIONAL
2009-07-31
2011-08-31
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
Ethinylestradiol/Gestogene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Interventions
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Ethinylestradiol/Gestogene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Eligibility Criteria
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Inclusion Criteria
* Normal cervical smear
* Smokers not older than 30 years
* History of regular cyclic menstrual periods
Exclusion Criteria
* Obesity (BMI\> 30 kg/m2)
* 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
35 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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Berlin, State of Berlin, Germany
Countries
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Related Links
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Click here and search for EMA websynopsis result
Other Identifiers
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2009-010599-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14287
Identifier Type: -
Identifier Source: org_study_id