Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC) - Full Text View

Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)

This study is currently recruiting participants.
Verified by Center for Epidemiology and Health Research, Germany, May 2008

Sponsors and Collaborators:	Center for Epidemiology and Health Research, Germany Organon
Information provided by:	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

MedlinePlus related topics:

Birth Control

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	25000
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2011

Groups/Cohorts

Users of NuvaRing

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

Contacts


Contact: Ruediger T Kolbeck, MSc	+49 30 94510142	kolbeck@zeg-berlin.de

Contact: Anita Assmann, MSc	+49 30 94510130	assmann@zeg-berlin.de

Locations


Germany
	Center for Epidemiology and Health Research	Recruiting
	Berlin, Germany, 10115
	Contact: Ruediger T Kolbeck, MSc +49 30 94510142 kolbeck@zeg-berlin.de
	Contact: Anita Assmann, MSc +49 30 94510130 assmann@zeg-berlin.de
	Principal Investigator: Juergen C Dinger, MD, PhD

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

Responsible Party:	Center for Epidemiology and Health Research, Germany ( Juergen C Dinger, MD, PhD, Principal Investigator )
Study ID Numbers:	ZEG2007_03
First Received:	September 4, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00524771
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

Contraception

Contraceptive Vaginal Ring

ClinicalTrials.gov processed this record on September 22, 2008