At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30,597 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 2
- ✓Women aged 40 or more years
- ✓Started use of a new oral HRT at the time of inclusion
Key exclusion· 1
- ✕Lack of consent to participate
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
European Active Surveillance Study of Women Taking HRT
Center for Epidemiology and Health Research, Germany·observational·Posted Sep 22, 2005·Updated Dec 1, 2014
In Brief
An observational study for Menopausal Symptoms. Completed, enrolled 30,597 participants across 1 site.
Detailed 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 focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users for up to 8.5 years.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMenopausal Symptoms
CountriesGermany
CollaboratorsBayer
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2004
First PostedSep 2005
Primary CompletionMay 2011
Study CompletionNov 2011
TodayJul 2026
First PostedSep 22, 2005
Enrollment StartNov 1, 2004
Primary CompletionMay 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 20.8 years ago