Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

  Hide Detailed Description

Detailed Description:

This is a large, multinational, controlled, prospective, active surveillance study of women who are prescribed NuvaRing® or an oral contraceptive (OC). The study follows two cohorts. The cohorts consist of new users (starters and switchers) of two different groups of hormonal contraceptives:

  • NuvaRing®
  • marketed combined OCs (combined oral contraceptives)

NuvaRing® is a transparent and flexible contraceptive vaginal ring containing etonogestrel and ethinylestradiol (EE). The ring releases 15 mcg EE and 120 mcg etonogestrel daily. After insertion it remains in the upper part of the vagina for 21 days, followed by 7 ring-free days before a new ring is inserted.

The primary objective of this study is to characterize and compare the risks of short- and long-term use of NuvaRing® with marketed combined OCs. The main clinical outcomes of interest for the short and long-term follow-up are:

  • Deep Venous Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Acute Myocardial Infarction (AMI)
  • Cerebrovascular Accidents (CVA)

Secondary objectives are:

  • to analyze the drug utilization pattern of NuvaRing® and marketed OCs in a study population that is representative for typical use of the individual contraceptive methods under routine medical conditions
  • to characterize the baseline risk of users of the individual formulations
  • to assess the compliance of NuvaRing® users and users of marketed OCs
  • to analyze the reasons for discontinuing the treatment with NuvaRing® and/or marketed OCs.

The study will use a non-interference approach to provide standardized, comprehensive, reliable information on these treatments in a routine clinical practice setting.

Study participants will be recruited via an international network of more than 1000 gynecologists. After study entry cohort members will be followed for a period of 30 to 48 months for rare serious safety outcomes. Regular, active contacts with the cohort members by the study team of the Berlin Center for Epidemiology and Health Research (ZEG), Germany will provide the necessary information on health-related events or changes in health status (= active surveillance).

Approximately 15,000 subjects per cohort will be recruited by participating physicians in order to provide approx. 86,000 women-years (WY) of observation. Subjects will be considered for enrollment in this study after the participating physician has determined that NuvaRing® or OC use is appropriate. There will be no specific inclusion/exclusion criteria. All women who are eligible are to be asked by their physician if they are willing to participate. As this a non-interventional study, the possibility to participate in the study should not be discussed with the patient before both - physician and patient - agree upon the prescription.

The study will be conducted in several European countries and the United States.

The study will be divided into 2 phases: a baseline survey which includes an initial consultation at baseline with a participating physician, and a follow-up phase which includes two follow-up contacts within the first year and then annual follow-up contacts for up to 4 years post-baseline.

The study will maintain scientific independence and will be governed by an independent Safety Monitoring and Advisory Council (SMAC). The Berlin Center for Epidemiology and Health Research (ZEG) and its research team will be accountable to the council in all scientific matters. The members of the council will be international experts in relevant scientific fields (e. g., epidemiology, drug safety, gynecology, cardiology, statistics, endocrinology).

  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 November 24, 2014