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

NCT03484260 | Completed

• 1 other identifier: 19547
• Study Type: observational
• Target: 27,778
• Locations: 1 country
• Sites: 1

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

Conditions

Hypogonadism

Keywords

Risk factors predicting the initiation of testosterone use

Outcome Measures

Primary Outcomes (1)

• Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy

  Retrospectively from 01 January 2001 to 31 March 2016

Study Arms (2)

Case group: Testosterone Product

Male subjects prescribed testosterone in UK

Drug: Testosterone Product

Control group

Matched male subjects not prescribed testosterone in the UK

Interventions

Testosterone Product DRUG

Men used testosterone product following prescription

Case group: Testosterone Product

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Berlin, 13342, Germany

Location

Related Links

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

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 30, 2018
• Study Start: April 1, 2018
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

DE (1)