Study Completed

Hypogonadism

Bayer Identifier:

19547

ClinicalTrials.gov Identifier:

NCT03484260

EudraCT Number:

Not Available

EU CT Number:

Not Available

Association between the Prevalence of cardiovascular risk factors and new use of testosterone

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - N/A

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.

Trial summary

Enrollment Goal

27778

Trial Dates

April 2018 - May 2018

Phase

Phase 4

Could I Receive a placebo

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Berlin, 13342, Germany

Primary Outcome

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

Trial design

Association between the prevalence of cardiovascular risk factors and new use of testosterone

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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