[Safety of long-term replacement hormonal therapy in patients with erectile dysfunction and androgen deficiency].

Safety of testosterone undecanoate in relation to initiation of cancer and prostatic adenoma (PA) in patients with androgenic deficiency and erectile dysfunction (ED) was studied for 12 months in 49 patients aged 57 to 73 years treated with intramuscular testosteron injections. The size of the prostate in patients with adenoma was 46.34 +/- 21.12 cm3 while in adenoma-free patients--19.11 +/- 6.57 sm3. Diabetes mellitus of type 2 (DM-2) was diagnosed in 46.9% patients. All the patients had documented hypogonadism and ED. Tests for PSA and transrectal ultrasound investigation was made in all the patients. 12 month testosterone therapy produced normalization of a mean level of testosterone in both groups, index of erectile function increased. In one patient PSA rose higher than normal value. None of the patients developed obstruction of the urinary tract. Body mass index, lipid spectrum and carbohydrate metabolism also improved. Thus, long-term therapy with testosterone undecanoate has no effect on PSA level, does not induce urinary obstruction with enlarged prostate. The presence of DM-2 is not a contraindication for androgen therapy in adenoma patients. By reducing body mass index, total cholesterol, triglycerides and LDLP, testosterone therapy lowers the risk of prostatic cancer.