Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 575,216
- Primary Endpoint
- Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year
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
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
Secondary Outcomes
No secondary outcomes reported