Transdermal testosterone gel increases serum testosterone levels in hypogonadal men in Taiwan with improvements in sexual function

A randomized, double-blind, placebo-controlled trial was conducted to ( 1) evaluate efficacy and safety of transdermal testosterone gel (AndroGel) for hypogonadal men in Taiwan, and ( 2) observe improvements in sexual function through international index of erectile function (IIEF) scores. Eligible hypogonadal men were randomized to receive 50 mg/day transdermal testosterone gel (TTG) or placebo for 3 months. Primary end point was change from baseline in total testosterone ( TT) and free testosterone ( FT). Secondary end points were change from baseline in serum hormone levels ( such as dihydrotestosterone (DHT), estradiol (E2), luteinizing hormone (LH), follicle-stimulating hormone (FSH) and sex-hormone-binding globulin ( SHBG)) and changes in IIEF scores. Safety evaluations included adverse events (AEs) and skin irritation assessment. Compared with baseline, the TTG group ( n = 20) had statistically significant increases in mean TT levels at month 1 ( P = 0.024) and month 2 ( P = 0.025), but no significant changes at month 3. TT levels in the placebo group ( n 18) showed no statistically significant change at any visit. Changes in FT levels paralleled changes in TT levels in both groups. TTG group IIEF scores were significantly increased at month 3 ( P = 0.01), compared with a decline in placebo scores. No drug-related AEs occurred in the TTG group; the placebo group had 2 AEs ( mild skin rash). In conclusion, TTG effectively restores serum TT and FT levels to a normal physiological range for hypogonadal men in Taiwan and improves sexual function.