European Active Surveillance Study (EURAS)

NCT00302848 | Completed Results DMC

• 1 other identifier: ZEG 2000_1
• Study Type: observational
• Target: 59,510
• Locations: 1 country
• Sites: 1

Brief Summary

EURAS is a multi-national, controlled, prospective, post-marketing, non-intervention cohort study of new users of drospirenone/ethinylestradiol (DRSP/EE), levonorgestrel/ethinylestradiol (LNG/EE) and other oral contraceptives (OCs) under routine conditions of medical practice in seven European countries. Baseline survey and semiannual, active follow-up are based on postal questionnaires, with validation of reported events by the women's treating physicians. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates. The objective of the study is the investigation of the incidence of rare serious adverse events associated with the use of new and established OCs, and specifically the incidence of thromboembolic events.

Conditions

Contraception

Keywords

Venous thromboembolism; Drospirenone

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Venous Thromboembolism (VTE)

  1.5 to 5 years

Study Arms (3)

Users of Drospirenone (DRSP)

Drug: Drospirenone

Users of Levonorgestrel (LNG)

Drug: Levonorgestrel

Users of other oral contraceptives (OCs)

Drug: Other progestin containing oral contraceptive

Interventions

Drospirenone DRUG

Users of Drospirenone (DRSP)

Levonorgestrel DRUG

Users of Levonorgestrel (LNG)

Other progestin containing oral contraceptive DRUG

Users of other oral contraceptives (OCs)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women prescribed hormonal contraceptives

You may qualify if:

• Women starting OC use or women switching OCs
• Women willing to participate in the active surveillance for several years

You may not qualify if:

• Women who have contraindications for OC use

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related Publications (2)

• Heinemann LA, Dinger J. Safety of a new oral contraceptive containing drospirenone. Drug Saf. 2004;27(13):1001-18. doi: 10.2165/00002018-200427130-00003.

  PMID: 15471507 RESULT

• Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception. 2007 May;75(5):344-54. doi: 10.1016/j.contraception.2006.12.019. Epub 2007 Feb 23.

  PMID: 17434015 RESULT

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

drospirenone; Levonorgestrel

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 15, 2006
• Study Start: November 1, 2000
• Study Completion: December 1, 2005
• Last Updated: November 20, 2009
• Results First Posted: November 20, 2009

Record last verified: 2009-11

Locations

DE (1)