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Trial record 97 of 404 for:    LEVONORGESTREL

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:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Tracking Information
First Submitted Date April 16, 2007
First Posted Date April 17, 2007
Results First Submitted Date December 17, 2015
Results First Posted Date January 25, 2016
Last Update Posted Date January 25, 2016
Study Start Date October 2006
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2015)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00461253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Official Title Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
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.
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 Type Observational
Study Design Observational Model: Case Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Breast Cancer
Intervention
  • 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.
Study Groups/Cohorts
  • 1
    Breast Cancer Cases
    Interventions:
    • Device: Levonorgestrel-releasing IUD
    • Device: Copper IUD
  • 2
    Matched Controls for Breast Cancer Cases
    Interventions:
    • Device: Levonorgestrel-releasing IUD
    • Device: Copper IUD
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 17, 2015)
25565
Original Enrollment
 (submitted: April 16, 2007)
8000
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00461253
Other Study ID Numbers ZEG2006_02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
Study Sponsor Center for Epidemiology and Health Research, Germany
Collaborators Bayer
Investigators
Principal Investigator: Juergen Dinger, MD, PhD Center for Epidemiology and Health Research
PRS Account Center for Epidemiology and Health Research, Germany
Verification Date December 2015