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European Active Surveillance Study (EURAS)

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ClinicalTrials.gov Identifier: NCT00302848
Recruitment Status : Completed
First Posted : March 15, 2006
Results First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:
Center for Epidemiology and Health Research, Germany

Study Description
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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.

Condition or disease Intervention/treatment
Contraception Drug: Drospirenone Drug: Levonorgestrel Drug: Other progestin containing oral contraceptive

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 Design
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Study Type : Observational
Actual Enrollment : 59510 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The European Active Surveillance Study on OC Prescribing Practice, Benefits and Safety (EURAS)
Study Start Date : November 2000
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Venous Thromboembolism (VTE) [ Time Frame: 1.5 to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women prescribed hormonal contraceptives
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302848


Locations
Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: Juergen C Dinger, MD, PhD Center for Epidemiology and Health Research
More Information
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Publications of Results:

Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Berlin Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00302848     History of Changes
Other Study ID Numbers: ZEG 2000_1
First Posted: March 15, 2006    Key Record Dates
Results First Posted: November 20, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009

Keywords provided by Center for Epidemiology and Health Research, Germany:
Venous thromboembolism
Drospirenone

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Drospirenone
Progestins
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
 Contraceptives, Oral, Synthetic
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Hormones