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

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

Study Overview

• Status: Completed
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: Testosterone Product

• Study Type: Observational
• Enrollment (Actual): 27778

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13342
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The source population is the subset of male patients in the Clinical Practice Research Datalink (CPRD) that has been linked to the Hospital Episodes Statistics (HES) database (CPRD-HES).

Cases will be defined by first testosterone use between 1st January 2001 and 31st March 2016 (study period). The date of the GP consultation associated with the first testosterone prescription will be designated as the index day. All cases will be required to be over 18 years on the index day, to have contributed for at least 2 years to the CPRD-HES link and to have no history of testosterone before the index day.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group: Testosterone Product; Male subjects prescribed testosterone in UK	Drug: Testosterone Product; Men used testosterone product following prescription
Control group; Matched male subjects not prescribed testosterone in the UK

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Risk factors predicting the initiation of testosterone use
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 19547

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No