More than eight years＇ hands-on experience with the novel long-acting parenteral testosterone undecanoate  

作　　者：Farid Saad Axel Kamischke Aksam Yassin Michael Zitzmann Markus Schubert Ffiedrich Jockenhovel HermannM. Behre Louis Gooren Eberhard Nieschlag 

机构地区：[1]Bayer-Schering, Department of Men＇s Health, Berlin, Germany [2]Gulf Medical College School of Medicine, Ajman, United Arab Emirates [3]Institute of Reproductive Medicine of the University of Munster, Munster, Germany [4]Department of Urology, Segeberger Kliniken, Norderstedt, Germany [5]Innere Medizin, Klinikum der Universitiit zu Koln, Koln, Germany [6]Evangelisches Krankenhaus Herne, Herne, Germany [7]Andrology Unit, Department of Urology, Martin-Luther UniversitT, Halle, Germany [8]Department of Endocrinology, Andrology Section, Vrije Universiteit Medical Center, Amsterdam, the Netherlands

出　　处：《Asian Journal of Andrology》2007年第3期291-297,共7页亚洲男性学杂志（英文版）

摘　　要：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.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.

关 键 词：testosterone treatment testosterone undecanoate pharmacokinetic profile clinical efficacy side effects sexual dysfunction male contraception 

分 类 号：R979.21[医药卫生—药品]