Abstract
Aims: Despite the prevalence of hypogonadism (testosterone deficiency [TD]) and widespread use of testosterone therapy (TTh), the effectiveness and safety of long-term testosterone use remains highly contested. Over the past 15 years, we have conducted a registry study of men with TD with a focus on several health outcomes associated with TTh. Design: Observational patient disease registry study. Materials and Methods: Noninterventional disease registry with prospective longitudinal data on a large sample of adult hypogonadal men (n = 858) who were treated in a single Urology Clinic. The registry evaluates men with symptomatic TD during a urological exam of patients who have not been previously treated with TTh. There were no inclusion/exclusion criteria. All hormone assays are carried out in a single laboratory. Standard-of-care treatment of each patient is the sole responsibility of the attending clinician. The registry data consist of comprehensive medical records and questionnaire data collected during patient visits. The registry has a dedicated statistician to ensure adequate statistical analyses of all outcome measures assessed. Main Outcome Measures: We measured the following parameters: height, weight, waist circumference, hemoglobin, hematocrit, fasting glucose, glycated hemoglobin, insulin, systolic and diastolic blood pressure, heart rate, lipids (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides), highly sensitive C-reactive protein, and total testosterone (T). We assessed quality of life, erectile and urinary function. Clinical parameters were measured two to four times a year. Data are analyzed in regular intervals. Results: As of 2019, 858 men have been enrolled, of whom 85 patients exhibited primary hypogonadism, and the remaining 773 exhibited secondary or functional hypogonadism. Findings from this registry study on the benefit of TTh on anthropometric parameters, cardiometabolic function, diabetes, and prostate health have been reported. Conclusions: This registry study has provided real-world clinical evidence and produced new important findings regarding the effectiveness and safety of long-term TTh in hypogonadal men.
Highlights
Clinical evidence suggests that testosterone therapy (TTh) is a long-term, if not lifelong, treatment
Forty-seven (61.8%) of men with primary hypogonadism had Klinefelter’s syndrome. Most of these patients had been referred by orthopedists with a suspicion of hypogonadism, because they had presented with back pain and osteoporosis at a young age, with the youngest of these patients being 33 years old
Since the initiation of the study in 2004, all patients have been under the care of the same urologist (A.H.) so that investigator bias can be excluded
Summary
Clinical evidence suggests that testosterone therapy (TTh) is a long-term, if not lifelong, treatment. A number of randomized controlled trials (RCTs) have been carried out in hypogondal men receiving TTh, most of these trials are of very short duration ranging from 1 to 36 months.[1] To date, there are only three prospective RCTs with a duration of 3 years.[2,3,4] Two of those clinical trials were not restricted to hypogonadal men,[2,4] and one trial included a group of men receiving a combination of T and finasteride, and only 24 men each received testosterone (T) or placebo.[3] Other long-term studies with 42 and 60 months’ duration were not placebocontrolled.[5,6]. Many RCTs on TTh screen a large number of men, exceeding thousands of patients, in their recruitment process after establishing substantial lists of inclusion and exclusion criteria This results in exclusion of thousands of patients producing study populations that significantly differ from the patient populations often presenting in physicians’ offices and clinics in their everyday practice
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