Status:
COMPLETED
European Active Surveillance Study (EURAS)
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Conditions:
Contraception
Eligibility:
FEMALE
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 ...
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 s...
Eligibility Criteria
Inclusion
- Women starting OC use or women switching OCs
- Women willing to participate in the active surveillance for several years
Exclusion
- Women who have contraindications for OC use
Key Trial Info
Start Date :
November 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
59510 Patients enrolled
Trial Details
Trial ID
NCT00302848
Start Date
November 1 2000
End Date
December 1 2005
Last Update
November 20 2009
Active Locations (1)
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1
Center for Epidemiology and Health Research
Berlin, Germany, 10115