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

NCT00523614 | Completed Results

• 1 other identifier: ZEG2007_02
• Study Type: observational
• Target: 3,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Keywords

venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1: Cases

2: Controls

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• women outside the defined age range
• women with severe language problems
• women who are not willing to participate

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer: collaborator

Study Sites (1)

Center for Epidemilogy and Health Research

Berlin, 10115, Germany

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This is an observational study. The possibility of bias and residual confounding cannot be entirely eliminated.

Results Point of Contact

• Title: Juergen Dinger, MD, PhD, Principal Investigator
• Organization: Berlin Center for Epidemiology and Health Research, Germany

dinger@zeg-berlin.de

+49 30 94510145

Study Officials

• Juergen C Dinger, MD, PhD

  Center for Epidemiology and Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: July 1, 2007
• Study Completion: June 1, 2008
• Last Updated: March 23, 2010
• Results First Posted: December 2, 2009

Record last verified: 2010-03

Locations

DE (1)