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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03484260

Enrollment

27778

Registered

2018-03-30

Start date

2018-04-01

Completion date

2018-05-15

Last updated

2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Keywords

Risk factors predicting the initiation of testosterone use

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

Interventions

DRUGTestosterone Product

Men used testosterone product following prescription

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy	Retrospectively from 01 January 2001 to 31 March 2016

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026