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

NCT00461253 | Completed Results DMC

• 1 other identifier: ZEG2006_02
• Study Type: observational
• Target: 25,565
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

Breast Cancer Cases

Device: Levonorgestrel-releasing IUD; Device: Copper IUD

2

Matched Controls for Breast Cancer Cases

Device: Levonorgestrel-releasing IUD; Device: Copper IUD

Interventions

Levonorgestrel-releasing IUD DEVICE

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

Also known as: Mirena

1; 2

Copper IUD DEVICE

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

1; 2

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• women who are not willing to participate

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer: collaborator

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related 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.

  PMID: 21310281 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Intrauterine Devices, Copper

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Intrauterine Devices, Medicated; Intrauterine Devices; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Limitations and Caveats

Limitations include information-bias, which cannot be entirely eliminated in retrospective studies. However, in this study recall is likely not to be differential between cases and controls.

Results Point of Contact

• Title: Dr. Jürgen Dinger
• Organization: Center for Epidemiology and Health Research, Germany

dinger@zeg-berlin.de

0049 (0) 30 945 101 20

Study Officials

• Juergen Dinger, MD, PhD

  Center for Epidemiology and Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 17, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 25, 2016
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

DE (1)