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NCT03484260 Clinical Trial

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

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03484260
Other study ID # 19547
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date May 15, 2018

Study information
Verified date May 2019
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 27778
Est. completion date May 15, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone Product
Men used testosterone product following prescription

Locations
Country Name City State
Germany Many Locations Berlin

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy Retrospectively from 01 January 2001 to 31 March 2016
See also
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Completed NCT02937740 - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ Phase 4
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Completed NCT01717768 - Oral Testosterone for the Treatment of Hypogonadism Phase 2
Terminated NCT01460654 - Testosterone and Alendronate in Hypogonadal Men Phase 2
Completed NCT00998933 - Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure Phase 1
Completed NCT00663793 - ORAL T-6: Oral Androgens in Man-6 Phase 1

External Links