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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Institute for Applied Economics and Health Research Aps
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01703520
First received: September 24, 2012
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Male Breast Cancer
 Drug: Finasteride

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multinational, Observational Registry-Based Study of a Potential Link Between Finasteride and Male Breast Cancer in 4 Nordic Countries

Resource links provided by NLM:

Drug Information available for: Finasteride
U.S. FDA Resources

Further study details as provided by Merck:

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: 270284
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Drug: Finasteride
Prescribed as per routine clinical practice in Denmark, Sweden, Finland, and Norway.
Other Names:
  • MK-0906
  • PROSCAR®
  • PROPECIA®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703520

Locations
Denmark
Institute of Applied Economics and Health Research Aps
Copenhagen K, Denmark, DK-1454
Sponsors and Collaborators
Merck
Institute for Applied Economics and Health Research Aps
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01703520     History of Changes
Other Study ID Numbers: 0906-162, 2003.021
Study First Received: September 24, 2012
Last Updated: April 24, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Merck:
Males breast cancer
Finasteride
PROSCAR®
PROPECIA®

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013