A reliable form of androgen substitution therapy in terms of favorable kinetics and tolerance as well as effective restoration of androgenicity is paramount in hypogonadal men. A new feasible modality is the intramuscular injection of the long-acting ester testosterone undecanoate (TU). DESIGN We report data from 22 patients (15 with primary and 7 with secondary hypogonadism) aged 30 to 65 years (mean 43.8 ± 8 years) who received injections of 1000 mg of TU (4ml - ampoules) for up to 8.5 years.
The medication was well tolerated and local irritation of the injection site was moderate and did not exceed a duration of 3 days. Indicating sufficient substitution, serum trough levels of testosterone were generally within the low normal range,. Individual dosing intervals ranged from 10 to 14 weeks. In accordance, patients reported restoration of sexual functions and convenient changes in mood patterns, e.g. gain of vigor and loss of depressiveness. Sensation of fluctuations in androgen concentrations was rarely reported, quite in contrast to short-acting testosterone esters. Hemoglobin concentrations and hematocrit were markedly elevated under treatment but remained within the normal range. Prostate size as assessed by transrectal ultrasound remained below 30 ml in all patients and PSA concentrations did not exceed 2.0 µg/L. Bone density as determined by quantitative computer tomography of the lumbar spine or phalangeal ultrasound generally improved in all patients. In general, changes in regard to metabolic parameters occurred during the first 6 months of therapy, except for bone density, which reached a plateau after 2 years. In summary, intramuscular injections of testosterone undecanoate represent a feasible, safe and well tolerated modality of androgen substitution in hypogonadal men.
Conflict of Interest: Dr F Saad Is A Paid Consultant Of Schering Ag
Financial Support/Funding: Schering AG
Recorded in Sydney Australia, April 2007