ClinicalTrials.Veeva

Menu

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

C

Center for Epidemiology and Health Research, Germany

Status

Completed

Conditions

Breast Cancer

Treatments

Device: Levonorgestrel-releasing IUD
Device: Copper IUD

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00461253
ZEG2006_02

Details and patient eligibility

About

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.

Full 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.

Enrollment

25,565 patients

Sex

Female

Ages

Under 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

25,565 participants in 2 patient groups

1
Description:
Breast Cancer Cases
Treatment:
Device: Copper IUD
Device: Levonorgestrel-releasing IUD
2
Description:
Matched Controls for Breast Cancer Cases
Treatment:
Device: Copper IUD
Device: Levonorgestrel-releasing IUD

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems