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

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT00523614
• Lead Sponsor: Center for Epidemiology and Health Research, Germany

Brief 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Study Completion: 2008-06
• Results First Submitted: 2009-06-22
• Results First Submitted QC: 2009-10-23
• Results First Posted: 2009-12-02
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-19
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3400

Inclusion Criteria

• cases: women with a venous thromboembolism who are between 15 and 49 years old
• control: women without a venous thromboembolism diagnosis who are between 15 and 49 years old

Exclusion Criteria

• women outside the defined age range
• women with severe language problems
• women who are not willing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)	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.

Trial Locations

Locations (1)

Center for Epidemilogy and Health Research; 🇩🇪 Berlin, Germany