Study Results
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Basic Information
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COMPLETED
PHASE3
393 participants
INTERVENTIONAL
2009-05-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1
Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)
0.55mg ethinylestradiol and 2.1mg gestodene
Arm 2
Norelgestromin/Ethinylestradiol (EVRA)
0.6mg ethinylestradiol and 6mg norelgestromin
Interventions
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Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)
0.55mg ethinylestradiol and 2.1mg gestodene
Norelgestromin/Ethinylestradiol (EVRA)
0.6mg ethinylestradiol and 6mg norelgestromin
Eligibility Criteria
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Inclusion Criteria
* Smokers must not be older than 30 at time of informed consent
* History of regular cyclic menstrual periods, normal cervical smear
Exclusion Criteria
* Obesity (BMI\>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment
18 Years
35 Years
FEMALE
Yes
Sponsors
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Parexel
INDUSTRY
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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Mödling, Lower Austria, Austria
Wiener Neustadt, Lower Austria, Austria
Graz, Styria, Austria
Wörgl, Tyrol, Austria
Bregenz, Vorarlberg, Austria
Graz, , Austria
Innsbruck, , Austria
Vienna, , Austria
Vienna, , Austria
Zeltweg, , Austria
Brno, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Písek, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
De Bilt, , Netherlands
Den Helder, , Netherlands
Heerlen, , Netherlands
Nijmegen, , Netherlands
Countries
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References
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Gruber D, Skrivanek A, Serrani M, Lanius V, Merz M. A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study. Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13.
Other Identifiers
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2008-007308-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13082
Identifier Type: -
Identifier Source: org_study_id
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