Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
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ClinicalTrials.gov Identifier: NCT00461253 |
Recruitment Status :
Completed
First Posted : April 17, 2007
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
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Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
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Study Type | Observational |
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Study Design | Observational Model: Case-Control |
Condition |
Breast Cancer |
Interventions |
Device: Levonorgestrel-releasing IUD Device: Copper IUD |
Enrollment | 25565 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cases | Controls |
---|---|---|
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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 were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany). |
Period Title: Overall Study | ||
Started | 10093 [1] | 40250 [2] |
Completed | 5113 [3] | 20452 [4] |
Not Completed | 4980 | 19798 |
Reason Not Completed | ||
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
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Baseline Characteristics
Arm/Group Title | Cases | Controls | Total | |
---|---|---|---|---|
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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 were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany). | Total of all reporting groups | |
Overall Number of Baseline Participants | 5113 | 20452 | 25565 | |
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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).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 5113 participants | 20452 participants | 25565 participants | |
44.5 (5.1) | 44.2 (5.1) | 44.3 (5.1) | ||
Gender
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 5113 participants | 20452 participants | 25565 participants |
Female | 5,113 | 20,452 | 25565 | |
Male | 0 | 0 | 0 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 5113 participants | 20452 participants | 25565 participants |
Germany | 1815 | 7260 | 9075 | |
Finland | 3298 | 13192 | 16490 |
Outcome Measures
Adverse Events
Limitations and Caveats
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
Results Point of Contact
Name/Title: | Dr. Jürgen Dinger |
Organization: | Center for Epidemiology and Health Research, Germany |
Phone: | 0049 (0) 30 945 101 20 |
EMail: | dinger@zeg-berlin.de |
Publications of Results:
Responsible Party: | Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany |
ClinicalTrials.gov Identifier: | NCT00461253 |
Other Study ID Numbers: |
ZEG2006_02 |
First Submitted: | April 16, 2007 |
First Posted: | April 17, 2007 |
Results First Submitted: | December 17, 2015 |
Results First Posted: | January 25, 2016 |
Last Update Posted: | January 25, 2016 |