Hematological and urological aspects of the safety of androgen substitution therapy using long-acting testosterone undecanoate in patients with hypogonadism

Abstract

The objective of this work was to evaluate hematological and urological safety of androgen substitution therapy by retrospective analysis of 40 medical histories of patients with hypogonadism. It was shown that treatment with testosterone undecanoate resulted in a significant increase of hemoglobin concentration and packed cell volume that did not however cause serious adverse events and did not require withdrawal of therapy. No statistically significant changes in prostate size or prostate specific antigen (PSA) level were documented in patients receiving androgen therapy. Clinically significant elevation of PSA was apparent in 12.5% of the patients in whom its initial level exceeded 2.5 ng/ml and also in patients with acromegaly. To conclude, the data obtained in this study point out to hematological and urological safety of androgen substitution therapy.