Status:
COMPLETED
European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Bayer
Conditions:
Menopausal Symptoms
Eligibility:
FEMALE
40+ years
Brief Summary
The objective of the active surveillance study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products. The primary focu...
Detailed Description
The safety of a novel drug product containing a new chemical entity should be assessed in an extensive post marketing safety surveillance program. It is also prudent to assess both, the safety outcome...
Eligibility Criteria
Inclusion
- All women aged 40 or more years who started use of a new oral HRT at the time of inclusion in the study
Exclusion
- Women who do not consent to participate in the study
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
30597 Patients enrolled
Trial Details
Trial ID
NCT00214903
Start Date
November 1 2004
End Date
November 1 2011
Last Update
December 1 2014
Active Locations (1)
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1
Center for Epidemiology and Health Research
Berlin, Germany, 10115