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
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

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 April 17, 2014