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

Venous Thromboembolism Clinical Trial

Official title:

Use of OCs Containing Dienogest and Risk of Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523614
• Other study ID #: ZEG2007_02
• Status: Completed
• Phase: N/A
• First received: August 30, 2007
• Last updated: March 19, 2010
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: March 2010
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3400
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Germany	Center for Epidemilogy and Health Research	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)	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.	01/2002 - 01/2008	Yes