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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Center for Epidemilogy and Health Research

Berlin, 10115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Center for Epidemiology and Health Research, Germany

Other

Collaborators

Bayer

Registry information

Official study title

Use of OCs Containing Dienogest and Risk of Venous Thromboembolism

Important dates

Study start: 2007
Study completion: 2008
First posted: Aug 31, 2007
Registry last updated: Mar 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed