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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Merck Sharp & Dohme Corp.
Sponsor:
Collaborator:
Institute for Applied Economics and Health Research Aps
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01703520
First received: September 24, 2012
Last updated: July 31, 2015
Last verified: July 2015

September 24, 2012
July 31, 2015
May 2011
December 2015   (final data collection date for primary outcome measure)
  • Person-Years of Exposure to Finasteride by Participant Age and Year [ Time Frame: Up to 14 years ] [ Designated as safety issue: No ]
  • Incidence Rates of Male Breast Cancer by Exposure to Finasteride [ Time Frame: Up to 14 years ] [ Designated as safety issue: Yes ]
  • All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride [ Time Frame: Up to 14 years ] [ Designated as safety issue: Yes ]
Same as current
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
Not Provided
Not Provided
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- and age-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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
428000
December 2015
December 2015   (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).
Male
35 Years and older
No
Contact: Toll Free Number 1-888-577-8839
Denmark
 
NCT01703520
0906-162, 2003.021
No
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.
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP