Overview

This trial is active, not recruiting.

Conditions bph, depression, suicide
Treatment 5ari
Sponsor Lawson Health Research Institute
Start date January 2003
End date December 2013
Trial size 200000 participants
Trial identifier NCT02876757, 2016 0906 192 000

Summary

In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
5ari
Exposure to finasteride/dutasteride

Primary Outcomes

Measure
Suicide (Based on administrative data elements from Ontario Registrar General Death database, National Ambulatory Care Reporting System, Hospital Discharge abstracts, and Ontario Regional Mental Health database)
time frame: Through study completition, an average of 18 months.

Secondary Outcomes

Measure
Suicide attempt (Based on administrative data elements from National Ambulatory Care Reporting System, and Ontario Regional Mental Health database)
time frame: Through study completition, an average of 18 months.
Depression (Based on administrative data elements from Hospital Discharge Abstract Database, and Ontario Regional Mental Health database and Ontario Health Insurance Plan)
time frame: Through study completition, an average of 18 months.

Eligibility Criteria

Male participants at least 66 years old.

Inclusion Criteria: - All men >66 years of age in Ontario between 2003-2013 Exclusion Criteria: - Non Ontario residents - No prescriptions filled in prior 180 days - Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment. - Prescription initiated during hospital admission or ER visit.

Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.