Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone

Bayer1 site in 1 country27,778 target enrollmentApril 1, 2018

ConditionsHypogonadism

InterventionsTestosterone Product

DrugsTestosterone Product

Overview

Phase: Not Applicable
Intervention: Testosterone Product
Conditions: Hypogonadism
Sponsor: Bayer
Enrollment: 27778
Locations: 1
Primary Endpoint: Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

We will investigate if testosterone is preferentially given to patients at higher risk of cardiovascular events. If this is the case, then observational studies may be prone to selection bias resulting in overestimation of the cardiovascular risk associated with testosterone when compared to a healthier population not taking testosterone

Registry

clinicaltrials.gov

Start Date

April 1, 2018

End Date

May 15, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All male individuals in the source population with a first testosterone use during the study period will be included as cases. The date of the GP consultation associated with the first testosterone prescription will be designated as the index day.

Exclusion Criteria

•Patients of less than 18 years on the index day, with less than 2-year contribution to the CPRD-HES link before the index day, or with use of testosterone before the study period will be excluded from the group of cases.