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

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

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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 |
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

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
Germany | |
Center for Epidemiology and Health Research | |
Berlin, Germany, 10115 |
Principal Investigator: | Juergen C Dinger, MD, PhD | Center for Epidemiology and Health Research |
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 Key Record Dates |
Results First Posted: | November 20, 2009 |
Last Update Posted: | November 20, 2009 |
Last Verified: | November 2009 |
Venous thromboembolism Drospirenone |
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 |