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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703520
First Posted: October 10, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institute for Applied Economics and Health Research Aps
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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. 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
Male Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Estimated Enrollment: 428000
Actual Study Start Date: May 1, 2011
Estimated Study Completion Date: April 1, 2018
Estimated Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

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).
  Contacts and Locations
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.
  More 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 Submitted: September 24, 2012
First Posted: October 10, 2012
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Males breast cancer
Finasteride
PROSCAR®
PROPECIA®

Additional relevant MeSH terms:
Breast Neoplasms, Male
Breast Neoplasms
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