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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00461253
Recruitment Status : Completed
First Posted : April 17, 2007
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Levonorgestrel-releasing IUD Device: Copper IUD Phase 4

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 Design

Study Type : Observational
Actual Enrollment : 25565 participants
Observational Model: Case Control
Official Title: Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Study Start Date : October 2006
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461253


Locations
Germany
Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research
More Information

Publications:
Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00461253     History of Changes
Other Study ID Numbers: ZEG2006_02
First Posted: April 17, 2007    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016
Last Verified: December 2015

Keywords provided by Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances