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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00523614
First received: August 30, 2007
Last updated: March 19, 2010
Last verified: March 2010
History of Changes

August 30, 2007
March 19, 2010
July 2007
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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.
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Complete list of historical versions of study NCT00523614 on ClinicalTrials.gov Archive Site
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Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism
Use of 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.

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.
Observational
Observational Model: Case Control
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Non-Probability Sample

Cases: women between 15 and 49 years old with a VTE diagnosed in Germany between 2002 and 2007

Controls: population sample
Venous Thromboembolism
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  • 1: Cases
  • 2: Controls
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3400
June 2008
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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
Female
15 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00523614
ZEG2007_02
No
Juergen C Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
Center for Epidemiology and Health Research, Germany
Bayer
Principal Investigator: Juergen C Dinger, MD, PhD Center for Epidemiology and Health Research
Center for Epidemiology and Health Research, Germany
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP