Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function
NCT ID: NCT01257984
Last Updated: 2014-10-28
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
508 participants
INTERVENTIONAL
2010-12-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
BAY86-5300
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function
Arm 2
BAY86-5300
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support
Interventions
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BAY86-5300
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function
BAY86-5300
0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Body mass index (BMI) \>/= 30.0 kg/m2
* Presence or a history of venous or arterial thrombotic/thromboembolic events
* Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg.
* Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use
* Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
* Severe dyslipoproteinemia
* Malignant or premalignant disease
* Uncontrolled thyroid disorder
* Chronic inflammatory bowel disease
* Severe renal insufficiency or acute renal failure
* History of migraine with focal neurologic symptoms
* Epilepsy
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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Paris, Paris, France
Biarritz, , France
Marly-le-Roi, , France
Nancy, , France
Olivet, , France
Paris, , France
Paris, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Heidelberg, Baden-Wurttemberg, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Wuppertal, North Rhine-Westphalia, Germany
Blankenburg, Saxony-Anhalt, Germany
Burg, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Gera, Thuringia, Germany
Kahla, Thuringia, Germany
Bologna, , Italy
Brescia, , Italy
Cagliari, , Italy
Catania, , Italy
Milan, , Italy
Modena, , Italy
Napoli, , Italy
Palermo, , Italy
Pavia, , Italy
Pisa, , Italy
Roma, , Italy
Siena, , Italy
Elda, Alicante, Spain
Barcelona, Barcelona, Spain
Córdoba, Córdoba, Spain
Boadilla del Monte, Madrid, Spain
Málaga, Málaga, Spain
Chesterfield, Derbyshire, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Bath, Somerset, United Kingdom
East Horsley, Surrey, United Kingdom
Bradford-on-Avon, Wiltshire, United Kingdom
Corsham, Wiltshire, United Kingdom
Cardiff, , United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2010-019902-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14701
Identifier Type: -
Identifier Source: org_study_id
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