More than eight years' hands-on experience with the novel long-acting parenteral testosterone undecanoate.
Testosterone (T) as a compound for treatment of T deficiency has been available for almost 70 years, but the pharmaceutical formulations have been less than ideal. Traditionally, injectable T esters have been used for treatment, but they generate supranormal T levels shortly after the 2-3 weekly injection interval. T levels then decline very rapidly, becoming subnormal during the days preceding the next injection. The rapid fluctuations in plasma T are subjectively experienced as disagreeable. T undecanoate (TU) is a new injectable T preparation with a considerably better pharmacokinetic profile. After two initial injections separated by a 6-week interval, the following intervals between two injections are generally 12 weeks, eventually amounting to a total of four injections per year. Plasma T levels with this preparation are nearly always in the range of normal men, as are its metabolic products estradiol and dihydrotestosterone (DHT). It reverses the effects of hypogonadism on bone and muscle and metabolic parameters, and on sex functions. It is suitable for male contraception. Its safety profile is excellent because of the continuous normalcy of plasma T levels. No polycythemia has been observed and no adverse effects on lipid profiles. Prostate safety parameters are well within reference limits. TU is a valuable treatment option of androgen deficiency.
Saad
Farid
F
Bayer-Schering Pharma, Men's Healthcare, 13342 Berlin, Germany. Farid.Saad@bayerhealthcare.com
Kamischke
Axel
A
Yassin
Aksam
A
Zitzmann
Michael
M
Schubert
Markus
M
Jockenhel
Friedrich
F
Behre
Hermann M
HM
Gooren
Louis
L
Nieschlag
Eberhard
E
D003272:Contraceptive Agents, Male / Q000493:pharmacokinetics / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D007273:Injections, Intramuscular; D008297:Male; D013739:Testosterone / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D045165:Testosterone Congeners / Q000493:pharmacokinetics / Q000627:therapeutic use*
D003272:Contraceptive Agents, Male; D045165:Testosterone Congeners; D013739:Testosterone; C010792:testosterone undecanoate