Adult- and late-onset male hypogonadism: the clinical practice guidelines of the Italian Society of Andrology and Sexual Medicine (SIAMS) and the Italian Society of Endocrinology (SIE).

Clinical diagnosis of adult-onset hypogonadism should be based on a combination of clinical and biochemical parameters.

• Recommendations were based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
• The guidelines were commissioned by the Italian Society of Andrology and Sexual Medicine (SIAMS) and the Italian Society of Endocrinology (SIE).
• The guidelines cover adult-onset and late-onset male hypogonadism specifically.

Testosterone replacement therapy (TRT) should be offered to all symptomatic subjects with hypogonadism after exclusion of possible contraindications.

• T gels and long-acting injectable T are identified as currently available preparations showing the best efficacy/safety profile.
• TRT can improve all aspects of sexual function, although its effect is limited in more complicated patients.
• Subjects must be correctly followed up as part of appropriate TRT management.

TRT improves body composition by reducing fat mass and increasing lean mass in subjects with or without metabolic syndrome or type 2 diabetes.

• The improvement in body composition was observed both in subjects with and without metabolic syndrome or type 2 diabetes.
• The role of TRT in improving glycometabolic control was described as 'more conflicting.'
• Body composition improvement was noted particularly in less complicated adult and aging subjects with hypogonadism.

TRT can result in increasing bone mineral density, particularly at the lumbar site, but no information on fracture risk is available.

• The increase in bone mineral density was specifically noted to be most pronounced at the lumbar site.
• No data on fracture risk reduction were available to support TRT recommendations for bone outcomes.
• This finding was derived from the evidence-based review conducted by the expert task force.

Limited data support the use of TRT for improving outcomes including mood, frailty, and mobility.

• The guidelines characterize the supporting evidence for these outcomes as 'limited.'
• Mood, frailty, and mobility were identified as additional potential outcomes of TRT beyond sexual function and body composition.
• These outcomes were contrasted with the stronger evidence base for sexual function and body composition improvements.

No short-term increased risk of adverse events is observed when hypogonadism is adequately diagnosed, testosterone appropriately prescribed, and subjects correctly followed up.

• The safety profile assessment applies specifically to short-term outcomes.
• The guidelines note that longer and larger studies are advisable to better clarify TRT long-term efficacy/safety profile.
• The safety conclusion is conditional on adequate diagnosis, appropriate prescription, and correct follow-up.