The reliability of clinical and biochemical assessment in symptomatic late-onset hypogonadism: can a case be made for a 3-month therapeutic trial?

OBJECTIVE: To assess whether testosterone (T) supplementation in men considered to have symptomatic late-onset hypogonadism (SLOH) can be evaluated clinically and biochemically. PATIENTS AND METHODS: To assess the relevance of the clinical and biochemical diagnosis of hypogonadism we investigated patients referred for the diagnosis and treatment of SLOH. Patients were assessed clinically and completed a screening questionnaire. The pituitary-adrenal-gonadal axis was comprehensively assessed biochemically. Those with a clinical diagnosis of hypogonadism and serum levels of T supporting such a diagnosis received exogenous T for >/= 3 months and were assessed for any clinical and biochemical response. Of an initial group of 45 men (mean age 59.2 years) 38 completed the study.
RESULTS: Most men presented with symptoms of sexual dysfunction, lack of energy and/or depression. There were differences before and after treatment only in bioavailable T (BT), with none in the levels of total T (TT). There was a strong correlation before and after treatment in the levels of luteinizing hormone and follicle-stimulating hormone, and a weak negative correlation between gonadotrophins and BT. Neither TT nor BT had predictive value for the treatment response. There was a trend to a correlation between BT levels and treatment success. Changes in serum prostate specific antigen were insignificant during the limited period.
CONCLUSION: The lack of accurate methods for diagnosing SLOH suggests that a therapeutic trial of T supplementation is warranted in men in whom there are no contraindications. The 3-month period largely circumvents the placebo effect and has minimal risks for serious adverse effects (mostly in relation to prostate safety). This controversial position needs further evaluation with a larger cohort and other biochemical measurements.