EU/LA Pearl Index Study - Transdermal Contraceptive Patch
NCT ID: NCT00914693
Last Updated: 2014-12-05
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
1694 participants
INTERVENTIONAL
2009-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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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/Gestodene (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/Gestodene (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
No
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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Lanús Oeste, Buenos Aires, Argentina
San Isidro, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Ashfield, New South Wales, Australia
Adelaide, South Australia, Australia
North Adelaide, South Australia, Australia
Clayton, Victoria, Australia
Nedlands, Western Australia, Australia
Temuco, Región de la Araucanía, Chile
Santiago, Santiago Metropolitan, Chile
Santiago, Santiago Metropolitan, Chile
Santiago, , Chile
Temuco, , Chile
Biarritz, , France
Montargis, , France
Nîmes, , France
Quetigny, , France
Reims, , France
Saint-Germain-en-Laye, , France
Toulouse, , France
Frankfurt am Main, Hesse, Germany
Aachen, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Siegen, North Rhine-Westphalia, Germany
Wuppertal, North Rhine-Westphalia, Germany
Dippoldiswalde, Saxony, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Blankenburg, Saxony-Anhalt, Germany
Jessen, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Gera, Thuringia, Germany
Francavilla Fontana, Brindisi, Italy
Bologna, , Italy
Cagliari, , Italy
Catanzaro, , Italy
Florence, , Italy
Modena, , Italy
Palermo, , Italy
Pavia, , Italy
Perugia, , Italy
Pisa, , Italy
Siena, , Italy
Chihuahua City, Chihuahua, Mexico
Torreón, Coahuila, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Mexico City, , Mexico
México D.F., , Mexico
México, D.F., , Mexico
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
San Fernando, Cádiz, Spain
Lugo, Lugo, Spain
Pamplona, Pamplona, Spain
Vigo, Pontevedra, Spain
Dos Hermanas, Sevilla, Spain
Alava, Vitoria, Spain
Zaragoza, Zaragoza, Spain
Barcelona, , Spain
Countries
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Related Links
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Click here and search for Bayer Product information provided by EMA
Other Identifiers
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2008-004214-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
310801
Identifier Type: OTHER
Identifier Source: secondary_id
91554
Identifier Type: -
Identifier Source: org_study_id