Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)
TASC
1 other identifier
observational
34,100
1 country
1
Brief Summary
The objective of this study is to characterize and compare the risks of short- and long-term use of NuvaRing® with marketed combined oral contraceptives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
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
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
April 9, 2014
CompletedApril 9, 2014
March 1, 2014
4.5 years
September 4, 2007
March 3, 2014
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Venous Thromboembolism (VTE)
Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
Time to event analysis within 48 months
Number of Participants With Arterial Thromboembolism (ATE)
Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
Time to event analysis within 48 months
Study Arms (2)
1
Users of NuvaRing
2
Users of combined oral contraceptives
Eligibility Criteria
Women prescribed hormonal contraceptives by gynecologists
You may qualify if:
- women who are prescribed NuvaRing® or a combined oral contraceptive and who are new users (Starters, restarters or switchers) of the formulation
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
- Organoncollaborator
Study Sites (1)
Berlin Center for Epidemiology and Health Research
Berlin, State of Berlin, 10115, Germany
Related Publications (1)
Dinger J, Mohner S, Heinemann K. Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring. Obstet Gynecol. 2013 Oct;122(4):800-808. doi: 10.1097/AOG.0b013e3182a5ec6b.
PMID: 24084537RESULT
Limitations and Caveats
In non-experimental studies 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
- Dr. Juergen Dinger
- Organization
- Center for Epidemiology and Health Research, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Juergen C Dinger, MD, PhD
Center for Epidemiology and Health Research Berlin, Germany
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
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 4, 2007
First Posted
September 5, 2007
Study Start
September 1, 2007
Primary Completion
March 1, 2012
Study Completion
June 1, 2012
Last Updated
April 9, 2014
Results First Posted
April 9, 2014
Record last verified: 2014-03