Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00461253
First received: April 16, 2007
Last updated: December 17, 2015
Last verified: December 2015
Results First Received: December 17, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control
Condition: Breast Cancer
Interventions: Device: Levonorgestrel-releasing IUD
Device: Copper IUD

  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
No text entered.

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 Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
Controls Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).

Participant Flow:   Overall Study
    Cases     Controls  
STARTED     10093 [1]   40250 [2]
COMPLETED     5113 [3]   20452 [4]
NOT COMPLETED     4980     19798  
Death                 985                 0  
Protocol Violation                 613                 236  
no response                 2609                 11789  
administrative                 773                 7773  
[1] Identified cases
[2] Identified controls
[3] Analyzed cases
[4] Analyzed controls



  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.
Definitions: cases were defined as women who were diagnised with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).

Reporting Groups
  Description
Cases Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
Controls Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
Total Total of all reporting groups

Baseline Measures
    Cases     Controls     Total  
Number of Participants  
[units: participants]
  5113     20452     25565  
Age  
[units: years]
Mean (Standard Deviation)
  44.5  (5.1)     44.2  (5.1)     44.3  (5.1)  
Gender  
[units: participants]
     
Female     5,113     20,452     25565  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Germany     1815     7260     9075  
Finland     3298     13192     16490  



  Outcome Measures

1.  Primary:   Breast Cancer Risk   [ Time Frame: retrospective, January 2000 to December 2007 ]


  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
Limitations include information-bias, which cannot be entirely eliminated in retrospective studies. However, in this study recall is likely not to be differential between cases and controls.


  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: Dr. Jürgen Dinger
Organization: Center for Epidemiology and Health Research, Germany
phone: 0049 (0) 30 945 101 20
e-mail: dinger@zeg-berlin.de


Publications of Results:

Responsible Party: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00461253     History of Changes
Other Study ID Numbers: ZEG2006_02
Study First Received: April 16, 2007
Results First Received: December 17, 2015
Last Updated: December 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices