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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism

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 Type: Observational
• Enrollment (Actual): 3400

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • Center for Epidemilogy and Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Controls: population sample

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1: Cases
2: Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Center for Epidemiology and Health Research, Germany
• Collaborators: Bayer
• Investigators: Principal Investigator: Juergen C Dinger, MD, PhD, Center for Epidemiology and Health Research

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: August 30, 2007
• First Submitted That Met QC Criteria: August 30, 2007
• First Posted (Estimate): August 31, 2007

Study Record Updates

• Last Update Posted (Estimate): March 23, 2010
• Last Update Submitted That Met QC Criteria: March 19, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: venous thromboembolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: ZEG2007_02