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The main indication for testosterone use is replacement therapy of male hypogonadism (for review: Nieschlag E, Behre HM, eds. Testosterone - action, deficiency, substitution. 3rd edition. Cambridge University Press, Cambridge, 2004). In secondary hypogonadism, hypothalamic or pituitary disorders result in decreased LH secretion and therefore insufficient testosterone production by testicular Leydig cells. In primary hypogonadism, the testis is unable to produce sufficient amounts of testosterone despite increased LH levels. Patients with primary and, if no fertility is desired, secondary hypogonadism require appropriate testosterone substitution to maintain androgen dependent functions. Late-onset hypogonadism (LOH) in males has become a topic of increasing interest and debate throughout the world. Recently, recommendations of the International Society of Andrology (ISA), the International Society for the Study of the Aging Male (ISSAM), and the European Association of Urology (EAU) have been published on investigation, treatment and monitoring of LOH in males (Nieschlag et al. Aging Male 2005;8:56-58). These recommendations provide clear statements on the indication for TRT in aging males with androgen deficiency. TRT should only be initiated if careful monitoring can be guaranteed, e.g. by patients' well-being, hematocrit and prostate function including PSA levels.