Clinical Trial: Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
Brief Summary: 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.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: September 24, 2012
Date Started: May 2011
Date Completion: June 2017
Last Updated: December 5, 2016
Last Verified: December 2016
