European Active Surveillance Study (EURAS)

• 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: Center for Epidemiology and Health Research, Germany
• Collaborator: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
• Information provided by: Center for Epidemiology and Health Research, Germany

Study Description

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

• 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

Groups and Cohorts

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

Primary Outcome Measures :

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

Eligibility Criteria

• 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

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

Publications of Results:

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.

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.

• Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Berlin Center for Epidemiology and Health Research, Germany
• ClinicalTrials.gov Identifier: NCT00302848
• Other Study ID Numbers: ZEG 2000_1
• First Posted: March 15, 2006
• 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:

Drospirenone; Contraceptive Agents; Levonorgestrel; Contraceptives, Oral; Progestins; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents; Hormones