NCT00523614

Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism

Use of OCs Containing Dienogest and Risk of Venous Thromboembolism

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,400 (actual)
• Sponsor: Center for Epidemiology and Health Research, Germany · Academic / Other
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Venous Thromboembolism

Timeline

• Start date: 2007-07-01
• Completion: 2008-06-01
• First posted: 2007-08-31
• Last updated: 2010-03-23
• Results posted: 2009-12-02

Locations

1 site across 1 country: Germany