European Active Surveillance Study (EURAS)

This study has been completed.
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00302848
First received: March 13, 2006
Last updated: November 6, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Contraception
Drug: Drospirenone
Drug: Levonorgestrel
Drug: Other progestin containing oral contraceptive
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The European Active Surveillance Study on OC Prescribing Practice, Benefits and Safety (EURAS)

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Number of Participants With Venous Thromboembolism (VTE) [ Time Frame: 1.5 to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 59510
Study Start Date: November 2000
Estimated Study Completion Date: December 2005
Groups/Cohorts Assigned Interventions
Users of Drospirenone (DRSP) Drug: Drospirenone
Users of Levonorgestrel (LNG) Drug: Levonorgestrel
Users of other oral contraceptives (OCs) 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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
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
Study First Received: March 13, 2006
Results First Received: June 23, 2009
Last Updated: November 6, 2009
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

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

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

ClinicalTrials.gov processed this record on October 19, 2014