NCT00461253

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25,565 (actual)
• Sponsor: Center for Epidemiology and Health Research, Germany · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Levonorgestrel-releasing IUD	This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
DEVICE	Copper IUD	This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.

Timeline

• Start date: 2006-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2007-04-17
• Last updated: 2016-01-25
• Results posted: 2016-01-25

Locations

1 site across 1 country: Germany