Baseline Data from the TRiUS Registry: Symptoms and Comorbidities of Testosterone Deficiency

Abstract

Background: Testosterone deficiency (TD) is prevalent among men seeking medical attention and may be associated with other comorbidities. Objective: The Testim® Registry in the United States (TRiUS), a large, multicenter, prospective, 12-month observational cohort registry, was established to quantify symptoms and comorbidities of hypogonadal men in real-world clinical settings and to evaluate the effect of testosterone replacement therapy (TRT). Methods: Eligible TRiUS participants were hypogonadal men prescribed Testim® (1% testosterone gel) for the first time. Evaluated baseline parameters included: total testosterone (TT), free testosterone (FT), sex hormone-binding globulin (SHBG), prostate-specific antigen (PSA), anthropometrics (height, weight, waist, hip, and body mass index [BMI]), lipids, blood glucose, sexual dysfunction, mood/depression, and cardiovascular and metabolic risk factors. Parameters were correlated to TT and age using bivariate correlation and to the combination of TT and age using multiple linear regression. Results: TRiUS had 849 registrants (baseline TT: 286.5 ± 151.8 ng/dL; FT: 40.8 ± 62.1 pg/mL; SHBG: 28.2 ± 15.0 nmol/L; PSA: 1.12 ± 1.11 ng/mL). Eighty-six percent were overweight/obese, with a BMI ≥ 25 kg/m², and 57% were aged 40 to 59 years, with a mean (± standard deviation) age of 52.1 ± 12.3 years. Total testosterone levels were significantly lower in men aged ≥ 65 years. The most common comorbid conditions and cardiovascular risk factors included: smoking, metabolic syndrome, hypertension, dyslipidemia, and coronary artery disease. Weak but statistically significant inverse correlations were noted between TT and sexual dysfunction, fasting glucose, systolic blood pressure, BMI, and Framingham risk scores. Patients with obesity or metabolic syndrome had significantly lower TT levels, particularly among younger and middle-aged patients. Conclusions: Untreated hypogonadal middle-aged men exhibited a high prevalence of cardiometabolic risk factors that were correlated to TT levels. This suggests that TD is associated with adverse medical conditions that pose serious health risks, especially in a younger age demographic than previously thought. Clinicians may want to consider TT testing in unhealthy, middle-aged patients with symptoms of TD.

Keywords:

• testosterone deficiency
• hypogonadism
• testosterone gel
• TRiUS
• Testim® registry