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Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703520
First Posted: October 10, 2012
Last Update Posted: December 4, 2017
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.
Collaborator:
Institute for Applied Economics and Health Research Aps
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 24, 2012
October 10, 2012
December 4, 2017
May 1, 2011
November 30, 2017   (Final data collection date for primary outcome measure)
  • Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year [ Time Frame: Up to 14 years ]
  • Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride [ Time Frame: Up to 14 years ]
  • Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride [ Time Frame: Up to 14 years ]
  • Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls [ Time Frame: Up to 19 years ]
  • Person-Years of Exposure to Finasteride by Participant Age and Year [ Time Frame: Up to 14 years ]
  • Incidence Rates of Male Breast Cancer by Exposure to Finasteride [ Time Frame: Up to 14 years ]
  • All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride [ Time Frame: Up to 14 years ]
Complete list of historical versions of study NCT01703520 on ClinicalTrials.gov Archive Site
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Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).
Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample
Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden
Male Breast Cancer
Not Provided
  • Male Finasteride Users
    Male finasteride users aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).
  • Male Finasteride Non-users
    Country-matched male finasteride non-users aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).
  • Men with Breast Cancer
    Breast cancer cases among men aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).
  • Men without Breast Cancer
    Country- and age-matched controls: men without breast cancer aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
428000
November 30, 2017
November 30, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant's study medical information available in population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, or Sweden within the observation period of 1995 to 2013
  • Male with breast cancer with medical information in one of the 4 country-specific registries in this study OR country- and age-matched control men without breast cancer and with medical information in one of the 4 country-specific registries
  • Study participant's exposure to finasteride is available

Exclusion Criteria:

For country- and age-matched control men without breast cancer

  • Previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer
  • Previous prostatectomy
  • Finasteride or dutasteride use (dutasteride is a drug in the same class as finasteride) within first 6 months of registration in the prescription registers (new user design).
Sexes Eligible for Study: Male
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Denmark
 
NCT01703520
0906-162
2003.021 ( Other Identifier: Merck )
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Institute for Applied Economics and Health Research Aps
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2017