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Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Center for Epidemiology and Health Research, Germany.
Recruitment status was  Active, not recruiting
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: October 21, 2011
Last verified: October 2011

April 16, 2007
October 21, 2011
October 2006
Not Provided
Breast Cancer Risk [ Time Frame: retrospective until January 2000 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00461253 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods
Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods

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 60 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 60 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 60 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 as the case came from.

Breast Cancer Risk
Not Provided
  • 1
    Cases
  • 2
    Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8000
Not Provided
Not Provided

Inclusion Criteria:

  • cases: women with a breast cancer who are younger than 60 years of age at cancer diagnosis
  • controls: women without a breast cancer diagnosis who are younger than 60 years at the time of the interview

Exclusion Criteria:

  • women who are not willing to participate
Female
up to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00461253
ZEG2006_02
Yes
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Center for Epidemiology and Health Research, Germany
Bayer
Principal Investigator: Juergen C Dinger, MD, PhD Center for Epidemiology and Health Research
Center for Epidemiology and Health Research, Germany
October 2011

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