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.
Institute for Applied Economics and Health Research Aps
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 24, 2012
Last updated: September 26, 2014
Last verified: September 2014
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.
Male Breast Cancer
||Observational Model: Cohort
Time Perspective: Retrospective
||A Multinational, Observational Registry-Based Study of a Potential Link Between Finasteride and Male Breast Cancer in 4 Nordic Countries
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
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.
Prescribed as per routine clinical practice in Denmark, Sweden, Finland, and Norway.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden
- 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
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No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2012
||September 26, 2014
||Denmark: Danish Health and Medicines Authority
Keywords provided by Merck Sharp & Dohme Corp.:
Males breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Breast Neoplasms, Male
Neoplasms by Site
5-alpha Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action