Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
The objective of this study is to compare the risk of venous thromboembolism (VTE) of oral contraceptives with non-use, focusing specifically on Valette® compared to other users of low estrogen dose combined oral contraceptives.
|Study Design:||Observational Model: Case Control|
|Official Title:||Use of OCs Containing Dienogest and Risk of Venous Thromboembolism|
- 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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||July 2007|
|Study Completion Date:||June 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523614
|Center for Epidemilogy and Health Research|
|Berlin, Germany, 10115|
|Principal Investigator:||Juergen C Dinger, MD, PhD||Center for Epidemiology and Health Research|