European Active Surveillance Study (EURAS)

November 6, 2009 updated by: Center for Epidemiology and Health Research, Germany

The European Active Surveillance Study on OC Prescribing Practice, Benefits and Safety (EURAS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 recruited by a selected set of physicians in six European countries. A total of more than 1,500,000 cycles are expected to be observed during the field work which will start early in 2001 and end early in 2006.

The participating women will undergo a baseline survey using a self administered questionnaire to describe the baseline risk. Every six months they will fill out a questionnaire in which they will record complaints and events during the use of the prescribed OC which will be validated. A multifaceted 4-level follow-up procedure will be established to ensure low loss to follow-up rates.

Based on experience obtained in previous OC studies complex sources of bias and confounding are expected. Thus, multivariate methods such as Cox regression will be used to adjust for confounding. Regarding the impact of the results on public health, the main emphasis will be on the absolute risk estimates.

Study Type

Observational

Enrollment (Actual)

59510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Center for Epidemiology and Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women prescribed hormonal contraceptives

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Users of Drospirenone (DRSP)
Drug: Drospirenone
Users of Levonorgestrel (LNG)
Drug: Levonorgestrel
Users of other oral contraceptives (OCs)
Drug: Other progestin containing oral contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Venous Thromboembolism (VTE)
Time Frame: 1.5 to 5 years
1.5 to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Collaborators

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators

  • Principal Investigator: Juergen C Dinger, MD, PhD, Center for Epidemiology and Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 6, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEG 2000_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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