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

April 16, 2007
December 17, 2015
October 2006
March 2014   (final data collection date for primary outcome measure)
Breast Cancer Risk [ Time Frame: retrospective, January 2000 to December 2007 ] [ Designated as safety issue: Yes ]
Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.
Not Provided
Complete list of historical versions of study NCT00461253 on ClinicalTrials.gov Archive Site
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Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.

Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.

A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.

Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

Observational
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample
Cases will be identified from population-based cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from.
Breast Cancer
  • Device: Levonorgestrel-releasing IUD
    This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
    Other Name: Mirena
  • Device: Copper IUD
    This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
  • 1
    Breast Cancer Cases
    Interventions:
    • Device: Levonorgestrel-releasing IUD
    • Device: Copper IUD
  • 2
    Matched Controls for Breast Cancer Cases
    Interventions:
    • Device: Levonorgestrel-releasing IUD
    • Device: Copper IUD
Dinger J, Bardenheuer K, Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception. 2011 Mar;83(3):211-7. doi: 10.1016/j.contraception.2010.11.009. Epub 2011 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25565
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
  • controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview

Exclusion Criteria:

  • women who are not willing to participate
Female
up to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00461253
ZEG2006_02
Yes
Not Provided
Not Provided
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Center for Epidemiology and Health Research, Germany
Bayer
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research
Center for Epidemiology and Health Research, Germany
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP