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

Center for Epidemiology and Health Research, Germany

Status: Completed

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00523614

ZEG2007_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,400 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,400 participants in 2 patient groups

1: Cases

2: Controls