Effect of long-term oral testosterone undecanoate treatment on prostate volume and serum prostate-specific antigen concentration in eugonadal middle-aged men

Testosterone undecanoate (160 mg/day) or placebo was given orally in a double-blind fashion for 8 months to 23 middle-aged men without urinary tract symptoms. Testosterone was found to increase the mean prostate volume by 12% (P < .012). The treatment suppressed the serum concentrations of sex-hormone-binding globulin and follicle stimulating hormone. The observed decrease in the mean serum concentration of luteinizing hormone was not statistically significant. The serum concentrations of prostate-specific antigen did not change as measured by two different well-validated immunometric assays. No changes in micturition habits or urine flow charts were reported.