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Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC) (TASC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524771
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Organon
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Tracking Information
First Submitted Date September 4, 2007
First Posted Date September 5, 2007
Results First Submitted Date March 3, 2014
Results First Posted Date April 9, 2014
Last Update Posted Date April 9, 2014
Study Start Date September 2007
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2014)
  • Number of Participants With Venous Thromboembolism (VTE) [ Time Frame: Time to event analysis within 48 months ]
    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 ]
    Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)
Official Title Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC)
Brief Summary 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.
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women prescribed hormonal contraceptives by gynecologists
Condition Contraception
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Users of NuvaRing
  • 2
    Users of combined oral contraceptives
Publications * Dinger J, Möhner S, Heinemann K. Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring. Obstet Gynecol. 2013 Oct;122(4):800-8. doi: 10.1097/AOG.0b013e3182a5ec6b.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 3, 2014)
34100
Original Estimated Enrollment
 (submitted: September 4, 2007)
12500
Actual Study Completion Date June 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00524771
Other Study ID Numbers ZEG2007_03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Study Sponsor Center for Epidemiology and Health Research, Germany
Collaborators Organon
Investigators
Principal Investigator: Juergen C Dinger, MD, PhD Center for Epidemiology and Health Research Berlin, Germany
PRS Account Center for Epidemiology and Health Research, Germany
Verification Date March 2014