Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)

This study is ongoing, but not recruiting participants.

First Received on September 4, 2007. Last Updated on November 2, 2011 History of Changes

Sponsor:	Center for Epidemiology and Health Research, Germany
Collaborator:	Organon
Information provided by (Responsible Party):	Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:	NCT00524771

Purpose

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.

Condition
Contraception

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:

Venous thromboembolism [ Time Frame: Time to event analysis within 48 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	33000
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2012

Groups/Cohorts
1 Users of NuvaRing
2 Users of combined oral contraceptives

Show Detailed Description

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women prescribed hormonal contraceptives by gynecologists

Criteria

Inclusion Criteria:

women who are prescribed NuvaRing® or an oral contraceptive and who are new users (starters or switchers) of the formulation

Exclusion Criteria:

women who do not consent to participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524771

Locations

Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115

Sponsors and Collaborators

Center for Epidemiology and Health Research, Germany

Organon

Investigators

Principal Investigator:

Juergen C Dinger, MD, PhD

Center for Epidemiology and Health Research Berlin, Germany

More Information

No publications provided

Responsible Party:	Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:	NCT00524771 History of Changes
Other Study ID Numbers:	ZEG2007_03
Study First Received:	September 4, 2007
Last Updated:	November 2, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Center for Epidemiology and Health Research, Germany:

Contraception
Contraceptive Vaginal Ring

Additional relevant MeSH terms:

Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012