European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
1 other identifier
observational
30,597
1 country
1
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 focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users for up to 8.5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
November 14, 2014
CompletedDecember 1, 2014
November 1, 2014
6.5 years
September 19, 2005
November 6, 2014
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)
Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
within 8.5 years
Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)
Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.
within 8.5 years
Study Arms (2)
1
New users of oral continuous combined HRT containing drospirenone
2
New users of oral continuous combined HRT containing other progestagens
Eligibility Criteria
Women aged 40 or more years using HRT
You may not qualify if:
- Women who do not consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Center for Epidemiology and Health Research, Germanylead
- Bayercollaborator
Study Sites (1)
Center for Epidemiology and Health Research
Berlin, 10115, Germany
Related Publications (1)
Dinger J, Bardenheuer K, Heinemann K. Drospirenone plus estradiol and the risk of serious cardiovascular events in postmenopausal women. Climacteric. 2016 Aug;19(4):349-56. doi: 10.1080/13697137.2016.1183624. Epub 2016 May 13.
PMID: 27174159DERIVED
Limitations and Caveats
In non-experimental studies like EURAS-HRT the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.
Results Point of Contact
- Title
- Juergen Dinger, MD, PhD
- Organization
- Center for Epidemiology and Health Research, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Juergen Dinger, MD, PhD
ZEG, Invalidenstrasse 115, 10115 Berlin, Germany
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 22, 2005
Study Start
November 1, 2004
Primary Completion
May 1, 2011
Study Completion
November 1, 2011
Last Updated
December 1, 2014
Results First Posted
November 14, 2014
Record last verified: 2014-11