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

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ClinicalTrials.gov Identifier: NCT01703520
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Institute for Applied Economics and Health Research Aps
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease
Male Breast Cancer

Study Type : Observational
Actual Enrollment : 575216 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
Actual Study Start Date : May 1, 2011
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

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

Group/Cohort
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-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).



Primary Outcome Measures :
  1. Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year [ Time Frame: Up to 14 years ]
  2. Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride [ Time Frame: Up to 14 years ]
  3. Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride [ Time Frame: Up to 14 years ]
  4. Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls [ Time Frame: Up to 19 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes 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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703520


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Institute for Applied Economics and Health Research Aps
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01703520     History of Changes
Other Study ID Numbers: 0906-162
2003.021 ( Other Identifier: Merck )
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by Merck Sharp & Dohme Corp.:
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
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents