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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461253
• Other study ID #: ZEG2006_02
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2007
• Last updated: December 17, 2015
• Start date: October 2006
• Est. completion date: March 2014

Study information

• Verified date: December 2015
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25565
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 50 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Levonorgestrel-releasing IUD
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.
• Copper IUD
This is a case-control-study; strictly speaking the category "intervention type" does not apply to this study.

Locations

Country	Name	City	State
Germany	Center for Epidemiology and Health Research	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany	Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Dinger J, Bardenheuer K, Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception. 2011 Mar;83(3):211-7. doi: 10.1016/j.contraception.2010.11.009. Epub 2011 Jan 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast Cancer Risk	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	Yes