Study of Efficacy and Safety of Non-scrotoal Testosterone Transdermal Delivery Sustem(Androderm Patch) in Male Hypogonadism

Paick, Jae Seung; Kim, Soo Woong

Abstract

PURPOSE: Although various attempts have been made and employed to restore normal testosterone levels in hypogonadal patients, it is still to be improved to achieve efficient hormone delivery. Recently a non-scrotal transdermal delivery system, Androderm patch, has been developed and proven to be of high efficacy and safety. We performed this study to examine the efficacy and safety of Androderm patch in Korean subjects.
MATERIALS AND METHODS
A total of 26 hypogonadal men who met the inclusion and exclusion criteria enrolled this study Subjects who had been treated with intramuscular administration of tetosterone had a 6-week washout period. After baseline evaluations, placebo patch was administered for 4 weeks and reexamined. Then patients received therapy over a 24-week period and were evaluated at 4-week intervals. The following efficacy parameters were evaluated at various time points during the study; serum concentrations of testosterone, bioavailable testosterone and estradiol, nocturnal penile tumescence test using Rigiscan, sexual function questionnaires, and hypogonadism symptoms. Also evaluated were safety parameters including skin tolerability, laboratory parameters, prostate evaluation and adverse events.
RESULTS
Fifteen patients were completed the study and included for data analysis. Most cause of drop-out cases(7/8) was local skin irritability. Testosterone level was increased from the pretreatment level of 91.5+/-83.3ng/dl to 503.1+/-177.6ng/dl during treatment. Bioavailable testosterone level was also increased significantly during treatment. Compared to baseline evaluations, significant improvements were shown in Rigiscan parameters(RAU & TAU values), sexual function scores and hypogonadism symptoms. No changes were found in safety parameters. However, it was also shown that a majority of patients(79.2%) experienced skin irritability with varying degree of reaction.
CONCLUSIONS
In conclusion, non-scrotal testosterone transdermal delivery system can produce physiologic serum androgen levels, improve objective and subjective sexual functions and reduce hypogonadal symptoms without any serious adverse reactions. However, it is suggested that the frequent skin irritability remains to be overcome for further improvement.