VIENNA—Testosterone replacement therapy benefits hypogonadal men without adversely affecting prostate safety, according to the largest international trial of hypogonadal men receiving the treatment.
In the trial, 1,438 hypogonadal men received 6,333 injections of injectable, long-acting testosterone undeconoate (TU) during 1,103 patient-years. Patients received up to five TU injections over nine to 12 months.
Study results, presented by Michael Zitzmann, MD, Professor of Medicine at the University of Muenster in Muenster, Germany, at the 26th Annual Congress of the European Association of Urology, demonstrated that the treatment improves erectile dysfunction and mental and sexual satisfaction without significantly impacting PSA levels. During the study, Dr. Zitzmann and his colleagues observed no case of prostate cancer.
“Testosterone replacement in hypogonadal men is a safe and highly effective medical procedure regarding multiple aspects of a man’s life,” Dr. Zitzmann told Renal & Urology News.
Testosterone replacement is not recommended for men with untreated cases of prostate cancer or those wishing to father a child, he noted, adding that the treatment reduces sperm counts.
During the study, the investigators monitored prostate safety by digital rectal examination and assessment of PSA levels. The overall mean PSA levels increased from 1.1 to 1.3 ng/mL but then remained stable. The proportion of men with moderate or severe erectile dysfunction decreased from 65% at baseline to 19% after TU therapy.
During the change from hypogonadism to eugonadism, the researchers noted, the proportion of men reporting a “high” or “very high” response to phosphodiesterase-5 inhibitors increased from 25% to 57%. Additionally, all scores of mental and sexual satisfaction (libido, vigor, overall mood, ability to concentration) increased markedly and mean waist circumference decreased significantly from 100 to 96 cm.
Stanton Honig, MD, Associate Professor of Urology at the University of Connecticut in Farmington, commented: “This large study confirms our belief that testosterone replacement is very safe in the hypogonadal male and the risks of prostate cancer related to this therapy are extremely low.”