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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT00461253
First received: April 16, 2007
Last updated: December 17, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Breast Cancer
Device: Levonorgestrel-releasing IUD
Device: Copper IUD
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

Resource links provided by NLM:


Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Breast Cancer Risk [ Time Frame: retrospective, January 2000 to December 2007 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 25565
Study Start Date: October 2006
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 16, 2007
Results First Received: December 17, 2015
Last Updated: December 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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

ClinicalTrials.gov processed this record on July 21, 2016