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Search / Trial NCT00302848

European Active Surveillance Study (EURAS)

Launched by CENTER FOR EPIDEMIOLOGY AND HEALTH RESEARCH, GERMANY · Mar 13, 2006

Trial Information

Current as of June 28, 2025

Completed

Keywords

Venous Thromboembolism Drospirenone

ClinConnect Summary

Active surveillance using valid epidemiologic study designs is desirable for any new product, because adverse effects may occur that have not yet been identified in pre-marketing studies.

The EURAS study investigates the safety of oral contraceptives with a large cohort of women attending offices of prescribing physicians. Its primary objective will be to compare incidence rates of adverse events in users of so-called new OCs and users of other OCs. The study is conducted as a phase IV commitment to the European Drug Authorities.

The combined cohort will include 50,000 to 60,000 women rec...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Women starting OC use or women switching OCs
  • Women willing to participate in the active surveillance for several years
  • Exclusion Criteria:
  • Women who have contraindications for OC use

About Center For Epidemiology And Health Research, Germany

The Center for Epidemiology and Health Research in Germany is a leading institution dedicated to advancing public health through rigorous epidemiological studies and clinical research. With a focus on understanding the determinants of health and disease, the center conducts innovative trials that aim to inform public health policies and improve health outcomes. Committed to fostering collaboration among researchers, healthcare professionals, and policymakers, the center employs state-of-the-art methodologies to generate evidence-based insights that address pressing health challenges. Through its comprehensive research initiatives, the center plays a pivotal role in enhancing the scientific foundation for health interventions and promoting community well-being.

Locations

Berlin, , Germany

Patients applied

0 patients applied

Trial Officials

Juergen C Dinger, MD, PhD

Principal Investigator

Center for Epidemiology and Health Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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