Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Other Contraceptive Methods

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Center for Epidemiology and Health Research, Germany.
Recruitment status was  Active, not recruiting
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: October 21, 2011
Last verified: October 2011
  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 Phase
Breast Cancer Risk
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 Other Contraceptive Methods

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 until January 2000 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: October 2006
Groups/Cohorts
1
Cases
2
Controls

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 60 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 60 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 60 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 60 Years
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 as the case came from.

Criteria

Inclusion Criteria:

  • cases: women with a breast cancer who are younger than 60 years of age at cancer diagnosis
  • controls: women without a breast cancer diagnosis who are younger than 60 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 C Dinger, MD, PhD Center for Epidemiology and Health Research
  More Information

No publications provided

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
Last Updated: October 21, 2011
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
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014