Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00524771
First received: September 4, 2007
Last updated: March 3, 2014
Last verified: March 2014
  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:


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

Primary Outcome Measures:
  • Number of Participants With Venous Thromboembolism (VTE) [ Time Frame: Time to event analysis within 48 months ] [ Designated as safety issue: Yes ]
    Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.

  • Number of Participants With Arterial Thromboembolism (ATE) [ Time Frame: Time to event analysis within 48 months ] [ Designated as safety issue: Yes ]
    Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.


Enrollment: 34100
Study Start Date: September 2007
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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 a combined oral contraceptive and who are new users (Starters, restarters or switchers) of the formulation

Exclusion Criteria:

  • women who do not consent to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Berlin 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

Publications:
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
Results First Received: March 3, 2014
Last Updated: March 3, 2014
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 October 23, 2014