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European Active Surveillance Study (EURAS)

NCT00302848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59510

Last updated 2009-11-20

Study results available
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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

Interventions

DRUG

Drospirenone

DRUG

Levonorgestrel

DRUG

Other progestin containing oral contraceptive

Sponsors & Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • Center for Epidemiology and Health Research, Germany

    lead OTHER

Principal Investigators

  • Juergen C Dinger, MD, PhD · Center for Epidemiology and Health Research

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-11-30
Completion
2005-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302848 on ClinicalTrials.gov