Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology.
OBJECTIVE
We developed clinical practice guidelines to assess the individual risk-benefit profile of androgen replacement therapy in adult male hypogonadism (HG), defined by the presence of specific signs and symptoms and serum testosterone (T) below 12 nmol/L.


METHODS
The task force consisted of eight clinicians experienced in treating HG, selected by the Italian Society of Endocrinology (SIE). The authors received no corporate funding or remuneration.


METHODS
Consensus was guided by a systematic review of controlled trials conducted on men with a mean T < 12 nmol/L and by interactive discussions. The guidelines were reviewed and sequentially approved by the SIE Guidelines Commission and Executive Committee.


CONCLUSIONS
We recommend T supplementation (TS) for adult men with severely reduced T levels (T < 8 nmol/L) to improve body composition and sexual function. We suggest that TS be offered to subjects with T < 12 nmol/L to improve glycaemic control, lipid profile, sexual function, bone mineral density, muscle mass and depressive symptoms, once major contraindications have been ruled out. We suggest that lifestyle changes and other available interventions (e.g. for erectile dysfunction) be suggested prior to TS. We suggest that TS should be combined with currently available treatments for individuals at high risk for complications, such as those with osteoporosis and/or metabolic disorders. We recommend against using TS to improve cardiac outcome and limited mobility. We recommend against using TS in men with prostate cancer, unstable cardiovascular conditions or elevated haematocrit. The task force places a high value on the timely treatment of younger and middle-aged subjects to prevent the long-term consequences of hypoandrogenism.
Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
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Isidori
Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy.
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Balercia
Department of Medical and Pediatric Sciences, University of Catania, Catania, Italy.
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Calogero
Medical Department Endocrinology Unit, Maggiore-Bellaria Hospital, Bologna, Italy.
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Corona
Department of Medicine, University of Padua, Padua, Italy.
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Ferlin
Department of Life, Health and Environment Sciences, Andrology, and Epidemiology, University of L'Aquila, L'Aquila, Italy.
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Francavilla
Department of Biosciences, Metabolism and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
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Santi
Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Viale Pieraccini 6, 50139, Firenze, Italy. m.maggi@dfc.unifi.it.
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Maggi
D000328:Adult; D000728:Androgens / Q000627:therapeutic use*; D004704:Endocrinology / Q000592:standards*; D020249:Hormone Replacement Therapy / Q000592:standards*; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D007558:Italy / Q000453:epidemiology; D008297:Male; D017410:Practice Guidelines as Topic / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012955:Societies, Medical / Q000592:standards*; D016896:Treatment Outcome
D000728:Androgens