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

December 17, 2015 updated by: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

25565

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Center for Epidemiology and Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Breast Cancer Cases
Device: Levonorgestrel-releasing IUD
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
Other Names:
  • Mirena
Device: Copper IUD
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
2
Matched Controls for Breast Cancer Cases
Device: Levonorgestrel-releasing IUD
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
Other Names:
  • Mirena
Device: Copper IUD
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cancer Risk
Time Frame: retrospective, January 2000 to December 2007
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.
retrospective, January 2000 to December 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Collaborators

Bayer

Investigators

  • Principal Investigator: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEG2006_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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