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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

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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

Study Type Observational
Study Design Observational Model: Case Control
Condition Breast Cancer
Interventions Device: Levonorgestrel-releasing IUD
Device: Copper IUD
Enrollment 25565
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cases Controls
Hide Arm/Group Description Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
Period Title: Overall Study
Started 10093 [1] 40250 [2]
Completed 5113 [3] 20452 [4]
Not Completed 4980 19798
Reason Not Completed
Death             985             0
Protocol Violation             613             236
no response             2609             11789
administrative             773             7773
[1]
Identified cases
[2]
Identified controls
[3]
Analyzed cases
[4]
Analyzed controls
Arm/Group Title Cases Controls Total
Hide Arm/Group Description Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany). Total of all reporting groups
Overall Number of Baseline Participants 5113 20452 25565
Hide Baseline Analysis Population Description
Definitions: cases were defined as women who were diagnised with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis. Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5113 participants 20452 participants 25565 participants
44.5  (5.1) 44.2  (5.1) 44.3  (5.1)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5113 participants 20452 participants 25565 participants
Female 5,113 20,452 25565
Male 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5113 participants 20452 participants 25565 participants
Germany 1815 7260 9075
Finland 3298 13192 16490
1.Primary Outcome
Title Breast Cancer Risk
Hide Description 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.
Time Frame retrospective, January 2000 to December 2007
Hide Outcome Measure Data
Hide Analysis Population Description
Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users
Arm/Group Title LNG IUD Cu-IUD
Hide Arm/Group Description:
Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
Overall Number of Participants Analyzed 5346 5428
Measure Type: Number
Unit of Measure: participants
1076 1068
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LNG IUD, Cu-IUD
Comments In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.88 to 1.12
Estimation Comments Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LNG IUD, Cu-IUD
Comments In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.93 to 1.17
Estimation Comments Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LNG IUD, Cu-IUD
Comments In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.52 to 1.39
Estimation Comments Breast cancer OR for "current use" of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LNG IUD, Cu-IUD
Comments In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.58 to 1.41
Estimation Comments Breast cancer OR for "current use" of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude
Time Frame Retrospective population based case-control study identifying breast cancer cases in the between January 2000 and December 2007 in women younger than 50 years of age at time of diagnosis.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LNG IUD Cu-IUD
Hide Arm/Group Description Users of LNG IUDs (Mirena) Users of copper IUDs
All-Cause Mortality
LNG IUD Cu-IUD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LNG IUD Cu-IUD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1085/5346 (20.30%)      1130/5428 (20.82%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  [1]  1085/5346 (20.30%)  1085 1130/5428 (20.82%)  1130
Indicates events were collected by systematic assessment
[1]
Breast cancer (in situ and invasive)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LNG IUD Cu-IUD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5346 (0.00%)      0/5428 (0.00%)    
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jürgen Dinger
Organization: Center for Epidemiology and Health Research, Germany
Phone: 0049 (0) 30 945 101 20
EMail: dinger@zeg-berlin.de
Layout table for additonal information
Responsible Party: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT00461253     History of Changes
Other Study ID Numbers: ZEG2006_02
First Submitted: April 16, 2007
First Posted: April 17, 2007
Results First Submitted: December 17, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016