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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03484260
• Collaborator: (none)
• Enrollment: 27,778
• Location: 1
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 19215.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: Testosterone Product

Study Design

• Study Type: Observational
• Actual Enrollment: 27778 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: May 15, 2018
• Actual Study Completion Date: May 15, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy [Retrospectively from 01 January 2001 to 31 March 2016]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Many Locations	Berlin		Germany	13342

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03484260
• Other Study ID Numbers: 19547
• First Posted: Mar 30, 2018
• Last Update Posted: May 14, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bayer: Risk factors predicting the initiation of testosterone use
• Additional relevant MeSH terms: Hypogonadism; Testosterone

Study Results

No Results Posted as of May 14, 2019