Overview

This trial is active, not recruiting.

Condition breast cancer risk
Phase phase 4
Sponsor Center for Epidemiology and Health Research, Germany
Collaborator Bayer
Start date October 2006
Trial size 8000 participants
Trial identifier NCT00461253, ZEG2006_02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Arm
Cases
Controls

Primary Outcomes

Measure
Breast Cancer Risk
time frame: retrospective until January 2000

Eligibility Criteria

Female participants up to 60 years old.

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

Additional Information

Official title Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods
Principal investigator Juergen C Dinger, MD, PhD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Center for Epidemiology and Health Research, Germany.