Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
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|ClinicalTrials.gov Identifier: NCT00523614|
Recruitment Status : Completed
First Posted : August 31, 2007
Results First Posted : December 2, 2009
Last Update Posted : March 23, 2010
|Condition or disease|
This is a population-based case-control study in Germany.
Cases are women who are between 15 and 49 years old with a diagnosis of venous thromboembolism (VTE). The VTE is diagnosed in Germany between January 2002 und December 2007.
Controls are women who are between 15 and 49 years old without a VTE diagnosis. About 4 controls matched by year of birth and region will be allocated to each case.
Both cases and controls will receive a similar self-administered questionnaire except of some case-specific questions which are not applicable for the controls.
Study participants will be asked for their informed consent. Data confidentiality will be ensured by the Berlin Center for Epidemiology and Health Research.
|Study Type :||Observational|
|Actual Enrollment :||3400 participants|
|Observational Model:||Case Control|
|Official Title:||Use of OCs Containing Dienogest and Risk of Venous Thromboembolism|
|Study Start Date :||July 2007|
|Study Completion Date :||June 2008|
- Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC) [ Time Frame: 01/2002 - 01/2008 ]The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.
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): NCT00523614
|Center for Epidemilogy and Health Research|
|Berlin, Germany, 10115|
|Principal Investigator:||Juergen C Dinger, MD, PhD||Center for Epidemiology and Health Research|