Use of Oral Contraceptives (OCs) Containing Dienogest and Risk of Venous Thromboembolism

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00523614
First received: August 30, 2007
Last updated: March 19, 2010
Last verified: March 2010
Results First Received: June 22, 2009  
Study Type: Observational
Study Design: Observational Model: Case Control
Condition: Venous Thromboembolism

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Identification started in spring 2007 and ended in January 2008. Cases (VTE=venous thromboembolism diagnosed in Germany between 01/2002 and 01/2008) were identified by primary care physicians. For each case 4 community-based controls (no VTE between 01/2002 and 01/2008) were selected.The controls were identified from randomly selected households.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cases Women with a venous thromboembolism who are between 15 and 49 years old
Controls Women without a venous thromboembolism diagnosis who are between 15 and 49 years old

Participant Flow:   Overall Study
    Cases     Controls  
STARTED     680 [1]   2720 [1]
COMPLETED     680 [1]   2720 [1]
NOT COMPLETED     0     0  
[1] As this is a case-control study the categories "started" and "completed" are not really applicable.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cases Women with a venous thromboembolism who are between 15 and 49 years old
Controls Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
Total Total of all reporting groups

Baseline Measures
    Cases     Controls     Total  
Number of Participants  
[units: participants]
  680     2720     3400  
Age  
[units: participants]
     
<=18 years     15     60     75  
Between 18 and 65 years     665     2660     3325  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.1  ± 9.0     36.1  ± 9.0     36.1  ± 9.0  
Gender  
[units: participants]
     
Female     680     2720     3400  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Germany     680     2720     3400  



  Outcome Measures

1.  Primary:   Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)   [ Time Frame: 01/2002 - 01/2008 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is an observational study. The possibility of bias and residual confounding cannot be entirely eliminated.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Juergen Dinger, MD, PhD, Principal Investigator
Organization: Berlin Center for Epidemiology and Health Research, Germany
phone: +49 30 94510145
e-mail: dinger@zeg-berlin.de


No publications provided


Responsible Party: Juergen C Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00523614     History of Changes
Other Study ID Numbers: ZEG2007_02
Study First Received: August 30, 2007
Results First Received: June 22, 2009
Last Updated: March 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices