Clinical experience with Andriol Testocaps--the first Austrian surveillance study on the treatment of late-onset hypogonadism.
OBJECTIVE
The objective of this study was to document the efficacy and tolerability of the new formulation of Andriol Testocaps in the treatment of late-onset hypogonadism in a clinical practice setting.


METHODS
The primary inclusion criterion was symptomatic testosterone deficiency, as confirmed by laboratory testing (morning total testosterone <12 nmol/L) on two separate occasions. The study was performed in 43 centres in Austria and a dosage of oral testosterone undecanoate of 2 x 80 mg/day was used for three months. The ADAM questionnaire, the AMS scale and the SF-36 questionnaire were administered by the patients and specific questions were asked to the prescribers.


RESULTS
A total of 189 patient report forms and 185 doctor report forms were completed. The average age of the participants was 54.7 +/- 12.3 years and average treatment duration was 13.9 +/- 2.2 weeks. Serum testosterone level increased by more than 50% from 8.7 +/- 4.3 nmol/L to 13.2 +/- 6.7 nmol/L (p < 0.001). Treatment improved symptoms on the ADAM and AMS scales, whereas no changes were observed on the SF-36. There were no significant effects on serum PSA levels.


CONCLUSIONS
Short-term treatment with oral testosterone undecanoate in a clinical practice setting improved late-onset hypogonadism symptoms in aging men with low testosterone levels.
Jungwirth
Andreas
A
Department of Urology and Andrology, EMCO Private Clinic, Martin Hell Strasse 7-9, Bad Dürrnberg, Austria. urologie@emco-klinik.at
Plas
Eugen
E
Geurts
Paul
P
D017668:Age of Onset; D000368:Aged; D001317:Austria; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood; D045165:Testosterone Congeners / Q000008:administration & dosage*
D045165:Testosterone Congeners; D013739:Testosterone; D017430:Prostate-Specific Antigen; C010792:testosterone undecanoate