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Trial record 40 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

European Active Surveillance Study (EURAS)

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: NCT00302848
Recruitment Status : Completed
First Posted : March 15, 2006
Results First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:
Center for Epidemiology and Health Research, Germany

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Contraception
Interventions Drug: Drospirenone
Drug: Levonorgestrel
Drug: Other progestin containing oral contraceptive
Enrollment 59510
Recruitment Details  
Pre-assignment Details A total of 59510 women were enrolled. Thereof 836 were excluded as they did not sign the informed consent form, were enrolled two or more times, continued their old OC or did not start OC use. In addition 371 used non oral hormonal contraception at study entry. These women were only used for the comparison of baseline risks.
Arm/Group Title Users of Drospirenone (DRSP) Users of Levonorgestrel (LNG) Users of Other Oral Contraceptives (OCs)
Hide Arm/Group Description Women who use oral contraceptives (OCs) containing DRSP as progestin Women who use oral contraceptives (OCs) containing LNG as progestin Women who use oral contraceptives (OCs) containing other progestins
Period Title: Overall Study
Started 16534 15428 26341
Completed 16133 [1] 15009 [1] 25762 [1]
Not Completed 401 419 579
[1]
Numbers completed refer to first follow-up. Individual follow-up ranged between 1.5 and 5.0 years.
Arm/Group Title Users of Drospirenone (DRSP) Users of Levonorgestrel (LNG) Users of Other Oral Contraceptives (OCs) Total
Hide Arm/Group Description Women who use oral contraceptives (OCs) containing DRSP as progestin Women who use oral contraceptives (OCs) containing LNG as progestin Women who use oral contraceptives (OCs) containing other progestins Total of all reporting groups
Overall Number of Baseline Participants 16534 15428 26341 58303
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16534 participants 15428 participants 26341 participants 58303 participants
<=18 years 3,454 4,215 6,307 13976
Between 18 and 65 years 13,080 11,213 20,034 44327
>=65 years 0 0 0 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16534 participants 15428 participants 26341 participants 58303 participants
25.9  (8.1) 25.1  (8.7) 24.8  (7.8) 25.2  (8.2)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16534 participants 15428 participants 26341 participants 58303 participants
Female 16,534 15,428 26,341 58303
Male 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 16534 participants 15428 participants 26341 participants 58303 participants
16,534 15,428 26,341 58303
1.Primary Outcome
Title Number of Participants With Venous Thromboembolism (VTE)
Hide Description [Not Specified]
Time Frame 1.5 to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis compares the users of DRSP and LNG. Its results are presented below. The comparison of users of DRSP and OCs containing other progestins was only conducted for exploratory reasons. This secondary analysis showed similar results and is described in more detail in the publication of study results, see "citations".
Arm/Group Title Users of DRSP Users of LNG
Hide Arm/Group Description:
Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
Overall Number of Participants Analyzed 16534 15428
Measure Type: Number
Unit of Measure: Participants
26 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Users of DRSP, Users of LNG
Comments Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0
Confidence Interval 95%
0.6 to 1.8
Estimation Comments [Not Specified]
Time Frame Between 1.5 and 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Users of Drospirenone (DRSP) Users of Levonorgestrel (LNG) Users of Other Oral Contraceptives (OCs)
Hide Arm/Group Description Women who use oral contraceptives (OCs) containing DRSP as progestin Women who use oral contraceptives (OCs) containing LNG as progestin Women who use oral contraceptives (OCs) containing other progestins
All-Cause Mortality
Users of Drospirenone (DRSP) Users of Levonorgestrel (LNG) Users of Other Oral Contraceptives (OCs)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Users of Drospirenone (DRSP) Users of Levonorgestrel (LNG) Users of Other Oral Contraceptives (OCs)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   965/16534 (5.84%)   1059/15428 (6.86%)   1815/26341 (6.89%) 
Blood and lymphatic system disorders       
Diseases of the blood and blood-forming organs   3/16534 (0.02%)  3/15428 (0.02%)  12/26341 (0.05%) 
Cardiac disorders       
Cardiovascular diseases   91/16534 (0.55%)  99/15428 (0.64%)  171/26341 (0.65%) 
Endocrine disorders       
Endocrine diseases   34/16534 (0.21%)  47/15428 (0.30%)  55/26341 (0.21%) 
Eye disorders       
Eye diseases   10/16534 (0.06%)  17/15428 (0.11%)  27/26341 (0.10%) 
Gastrointestinal disorders       
Digestive diseases   121/16534 (0.73%)  124/15428 (0.80%)  195/26341 (0.74%) 
General disorders       
Other   27/16534 (0.16%)  38/15428 (0.25%)  50/26341 (0.19%) 
Infections and infestations       
Infectious diseases   51/16534 (0.31%)  48/15428 (0.31%)  82/26341 (0.31%) 
Injury, poisoning and procedural complications       
Injuries   192/16534 (1.16%)  207/15428 (1.34%)  372/26341 (1.41%) 
Musculoskeletal and connective tissue disorders       
Diseases of the musculoskeletal system   151/16534 (0.91%)  162/15428 (1.05%)  261/26341 (0.99%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant neoplasms   10/16534 (0.06%)  12/15428 (0.08%)  25/26341 (0.09%) 
Benign neoplasms   61/16534 (0.37%)  64/15428 (0.41%)  117/26341 (0.44%) 
Psychiatric disorders       
Psychiatric and neurological diseases   43/16534 (0.26%)  58/15428 (0.38%)  109/26341 (0.41%) 
Renal and urinary disorders       
Genitourinary diseases   91/16534 (0.55%)  94/15428 (0.61%)  178/26341 (0.68%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory diseases   21/16534 (0.13%)  27/15428 (0.18%)  41/26341 (0.16%) 
Skin and subcutaneous tissue disorders       
Skin diseases   59/16534 (0.36%)  59/15428 (0.38%)  120/26341 (0.46%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Users of Drospirenone (DRSP) Users of Levonorgestrel (LNG) Users of Other Oral Contraceptives (OCs)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16534 (0.00%)   0/15428 (0.00%)   0/26341 (0.00%) 
This is an observational study. The possibility of bias and residual confounding cannot be entirely eliminated.
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: Juergen Dinger, MD, PhD, Principal Investigator
Organization: Berlin Center for Epidemiology and Health Research, Germany
Phone: +49 30 94510145
EMail: dinger@zeg-berlin.de
Layout table for additonal information
Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Berlin Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00302848     History of Changes
Other Study ID Numbers: ZEG 2000_1
First Submitted: March 13, 2006
First Posted: March 15, 2006
Results First Submitted: June 23, 2009
Results First Posted: November 20, 2009
Last Update Posted: November 20, 2009