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

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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Contraception
Enrollment 34100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NuvaRing Combined Oral Contraceptives (COC)
Hide Arm/Group Description Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring Users of combined oral contraceptive pills
Period Title: Overall Study
Started 17084 17016
Completed 16864 [1] 16431 [1]
Not Completed 220 585
Reason Not Completed
Protocol Violation             220             585
[1]
Numbers completed refer to first follow-up. Individual follow-up ranged between 0.5 and 4.0 years.
Arm/Group Title NuvaRing Combined Oral Contraceptives (COC) Total
Hide Arm/Group Description Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring Users of combined oral contraceptive pills Total of all reporting groups
Overall Number of Baseline Participants 16864 16431 33295
Hide Baseline Analysis Population Description
All study participants that were not excluded due to protocol violations.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16864 participants 16431 participants 33295 participants
28.0  (7.3) 26.9  (7.6) 27.4  (7.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16864 participants 16431 participants 33295 participants
<=18 years
127
   0.8%
406
   2.5%
533
   1.6%
Between 18 and 65 years
16737
  99.2%
16025
  97.5%
32762
  98.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16864 participants 16431 participants 33295 participants
Female
16864
 100.0%
16431
 100.0%
33295
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16864 participants 16431 participants 33295 participants
Europe 8215 7699 15914
United States 8649 8732 17381
1.Primary Outcome
Title Number of Participants With Venous Thromboembolism (VTE)
Hide Description Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
Time Frame Time to event analysis within 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study participants that were not excluded due to protocol violations.
Arm/Group Title NuvaRing Combined Oral Contraceptives (COC) COC2
Hide Arm/Group Description:
Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
Users of combined oral contraceptive pills
A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
Overall Number of Participants Analyzed 16864 16431 13811
Measure Type: Number
Unit of Measure: participants
19 26 21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NuvaRing, Combined Oral Contraceptives (COC)
Comments Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.5 to 1.5
Estimation Comments Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NuvaRing, COC2
Comments Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on the primary statistical analysis (see above).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.4 to 1.7
Estimation Comments Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NuvaRing, Combined Oral Contraceptives (COC)
Comments Like analysis 1 (see above) but restricted to exposure period of less than 6 months.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on the primary statistical analysis (see above).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.3 to 2.2
Estimation Comments Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NuvaRing, Combined Oral Contraceptives (COC)
Comments Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on the primary statistical analysis (see above).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.3 to 2.6
Estimation Comments Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NuvaRing, Combined Oral Contraceptives (COC)
Comments Like analysis 1 (see above) but restricted to exposure period of > 12 months.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on the primary statistical analysis (see above).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.3 to 2.3
Estimation Comments Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.
2.Primary Outcome
Title Number of Participants With Arterial Thromboembolism (ATE)
Hide Description Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.
Time Frame Time to event analysis within 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NuvaRing Combined Oral Contraceptives (COC) COC2
Hide Arm/Group Description:
Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
Users of combined oral contraceptive pills
A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
Overall Number of Participants Analyzed 16864 16431 13811
Measure Type: Number
Unit of Measure: participants
5 8 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NuvaRing, Combined Oral Contraceptives (COC)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on the primary statistical analysis (see above).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.2 to 2.3
Estimation Comments The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NuvaRing, COC2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations were based on the primary statistical analysis (see above).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.2 to 2.6
Estimation Comments Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.
Time Frame Information on adverse events was collected over a period of 4 years.
Adverse Event Reporting Description All study participants were asked for adverse events at each follow-up.
 
Arm/Group Title NuvaRing Combined Oral Contraceptives (COC)
Hide Arm/Group Description Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring Users of combined oral contraceptive pills
All-Cause Mortality
NuvaRing Combined Oral Contraceptives (COC)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
NuvaRing Combined Oral Contraceptives (COC)
Affected / at Risk (%) Affected / at Risk (%)
Total   577/17084 (3.38%)   751/17016 (4.41%) 
Blood and lymphatic system disorders     
Diseases of the blood and blood-forming organs  1  3/17084 (0.02%)  3/17016 (0.02%) 
Cardiac disorders     
Cardiovascular system  1  53/17084 (0.31%)  75/17016 (0.44%) 
Ear and labyrinth disorders     
Ear  1  8/17084 (0.05%)  9/17016 (0.05%) 
Endocrine disorders     
Endocrine diseases  1  7/17084 (0.04%)  8/17016 (0.05%) 
Eye disorders     
Eye  1  3/17084 (0.02%)  5/17016 (0.03%) 
Gastrointestinal disorders     
Digestive system  1  126/17084 (0.74%)  169/17016 (0.99%) 
Infections and infestations     
Infectious diseases  1  20/17084 (0.12%)  30/17016 (0.18%) 
Injury, poisoning and procedural complications     
Injury, poisening, accidents, etc  1  102/17084 (0.60%)  125/17016 (0.73%) 
Musculoskeletal and connective tissue disorders     
Muscosceletal system & connective tissue  1  19/17084 (0.11%)  26/17016 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms, malignant  1  14/17084 (0.08%)  19/17016 (0.11%) 
Neoplasms, benign  1  9/17084 (0.05%)  10/17016 (0.06%) 
Psychiatric disorders     
Psychiatric & neurological disorders  1  42/17084 (0.25%)  52/17016 (0.31%) 
Reproductive system and breast disorders     
Genitourinary system  1  112/17084 (0.66%)  144/17016 (0.85%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory system  1  40/17084 (0.23%)  54/17016 (0.32%) 
Skin and subcutaneous tissue disorders     
Skin  1  19/17084 (0.11%)  22/17016 (0.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD 10
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NuvaRing Combined Oral Contraceptives (COC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16864 (0.00%)   0/16431 (0.00%) 
In non-experimental studies the possibility of bias and residual confounding can never be entirely eliminated. The findings may exclude large, but not small relative risks.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Juergen Dinger
Organization: Center for Epidemiology and Health Research, Germany
Phone: 0049 (0)30 945 101 20
EMail: dinger@zeg-berlin.de
Layout table for additonal information
Responsible Party: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00524771    
Other Study ID Numbers: ZEG2007_03
First Submitted: September 4, 2007
First Posted: September 5, 2007
Results First Submitted: March 3, 2014
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014