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OpenTrials
Completed

NCT Number: NCT00461253

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.

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Key information

Age range

Up to 50 year

Sex eligibility

Female

Study type

Observational

Primary location

Center for Epidemiology and Health Research

Berlin, 10115, Germany

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levonorgestrel-releasing IUD

Device

This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.

Other names: Mirena

Copper IUD

Device

This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Center for Epidemiology and Health Research, Germany

Other

Collaborators

  • Bayer

Registry information

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2007
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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