Efficacy and Safety of Testosterone Gel in Korean Men with Late-onset Hypogonadism: A Prospective, Fixed-dose, Placebo-uncontrolled, Open-label, Multicenter Study / 대한남성과학회지

ABSTRACT

PURPOSE: We evaluated the efficacy and safety of transdermal 1% testosterone gel in Korean men with late-onset hypogonadism from Aug. 2004 to Dec. 2005 in a prospective, fixed-dose, placebo-uncontrolled, open label, multicenter study. MATERIALS AND METHODS: From the 5 urological centers in Korea, a total of 87 male patients older than 40 years who were diagnosed with late-onset hypogonadism with serum testosterone lower than 350 ng/dl or serum free testosterone lower than 73.5 pg/ml were enrolled. Among the 87 enrolled 68 patients completed the daily application of 1% testosterone gel according to the standard consumer guidelines for the full 12-week period. We compared the data at baseline and at 4, 8, and 12 weeks follow-up using the Aging Males' Symptoms (AMS) scale, the International Index of Erectile Function (IIEF)-15, the International Prostate Symptoms Score (IPSS), and the serum levels of total and free testosterone and prostate specific antigen (PSA). RESULTS: The mean age of the patients was 56.5+/-12.7 years. The total scores for the AMS scores at baseline, 4, 8, and 12 weeks were 43.5+/-12.2, 36.6+/-12.3, 33.8+/-11.2, and 34.2+/-11.0, respectively (p<0.0001 vs. baseline). Total and free testosterone levels at baseline were 259.8+/-119.4 ng/dl and 50.5+/-24.7 pg/ml, and at 12 weeks were 594.5+/-376.6 ng/dl and 139.5+/-110.7 pg/ml, respectively (p<0.0001 vs. baseline). IIEF scores increased from 34.7+/-8.5 at baseline to 43.2+/-8.7 at 12 weeks (p<0.0001). There were no significant changes in serum PSA levels. The most commonly reported adverse events were acne and itching at the site of application. The majority of adverse events were mild, reversible, and short in duration. CONCLUSIONS: Testogel(R) showed highly effective clinical and biochemical recovery with good tolerance in Korean men with late-onset hypogonadism.