An Observational Registry-Based Study of a Potential Link Between Finasteride (MK-0906) and Male Breast Cancer in 4 Nordic Countries (MK-0906-162/2003.021)

This study is ongoing, but not recruiting participants.
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 23, 2014
Last verified: July 2014

September 24, 2012
July 23, 2014
May 2011
March 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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An Observational Registry-Based Study of a Potential Link Between Finasteride (MK-0906) and Male Breast Cancer in 4 Nordic Countries (MK-0906-162/2003.021)
A Multinational, Observational Registry-Based Study of a Potential Link Between Finasteride and Male Breast Cancer in 4 Nordic Countries

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.

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
Drug: Finasteride
Prescribed as per routine clinical practice in Denmark, Sweden, Finland, and Norway.
Other Names:
  • MK-0906
  • PROSCAR®
  • PROPECIA®
  • Breast Cancer Cases Among Men with No Exposure to Finasteride
    The number of new cases of male breast cancer among men with no exposure to finasteride in the registries of Denmark, Finland, Sweden, and Norway.
  • Breast Cancer Cases Among Men with Exposure to Finasteride
    The number of new cases of male breast cancer among men exposed to finasteride in the registries of Denmark, Finland, Sweden, and Norway.
    Intervention: Drug: Finasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270284
March 2015
March 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 2009
  • Male with breast cancer with medical information in one of the 4 country-specific registries in this study
  • Study participant's exposure to finasteride is available
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01703520
0906-162, 2003.021
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Institute for Applied Economics and Health Research Aps
Not Provided
Merck Sharp & Dohme Corp.
July 2014

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