Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men

Abstract

The study objective was to evaluate the efficacy of changing testosterone gel preparations among suboptimally responsive hypogonadal men. The records of all hypogonadal men on gel (Testim or Androgel) testosterone replacement therapy (TRT) were reviewed to identify men who underwent a brand substitution in gel TRT due to initial suboptimal response. Total and free serum testosterone levels and the presence of hypogonadal symptoms (ADAM) were compared pre-and post-gel substitution. Of the 370 hypogonadal men on testosterone gel replacement therapy, 75 (20%) underwent a brand substitution. Prior to substitution, among patients initially treated with Androgel, the mean total and free testosterone levels were 311 ng dl À1 and 10.4 pg ml À1 , respectively. Total testosterone levels were below 300 ng dl À1 in 58% of these patients. Following a change to Testim, mean total and free testosterone levels increased to 484 ng dl À1 (Po0.001) and 14.6 pg ml À1 (P ¼ 0.01), respectively. Total testosterone levels remained below 300 ng dl À1 in only 17% of these patients. Among patients initially treated with Testim, the mean total and free testosterone levels were 544 ng dl À1 and 18.0 pg ml À1 , respectively. Total testosterone levels were below 300 ng dl À1 in 15% of men. Following testosterone gel change to Androgel, mean total and free testosterone levels were 522 ng dl À1 (P ¼ 0.7) and 16.1 pg ml À1 (P ¼ 0.6), respectively. Total testosterone levels remained below 300 ng dl À1 in 27% of these patients. Hypogonadal symptoms improved in a significant proportion of men who underwent a brand substitution following an initial suboptimal biochemical or symptomatic response. A change in testosterone gel preparation among initially unresponsive hypogonadal men is justified prior to abandoning or considering more invasive TRT. Changing from Androgel to Testim offers hypogonadal men the potential for improved clinical and biochemical responsiveness. Changing from Testim to Androgel is indicated to eliminate or minimize unwanted side effects.

Oxidative Stress, Testosterone, and Cognition among Caucasian and Mexican-American Men with and without Alzheimer's Disease

“…However, in contrast to findings in younger hypogonadal men, the protective effects of TRT in older men have been equivocal [8–13]. For example, 20–28% of aging men experience either no response or a negative adverse event in response to TRT [10, 14]. Importantly, these adverse effects of TRT appear to be concentration dependent, with serious adverse effects observed in 28% of aging men with testosterone levels >10 ng/ml, 23% of aging men with 5–10 ng/ml total testosterone, and 15% of aging men with testosterone <5 ng/ml [15].…”

Testosterone Replacement Therapy in Men With Hypogonadism and HIV/AIDS: Results From the TRiUS Registry

“…28 Other studies of Testim ® use of 3 to 12 months' duration reported comparable increases in TT levels. 27,46,47 Data on changes in TT and FT levels in men with HIV/ AIDS treated with topical testosterone gels are scarce. One prospective, randomized, open-label study of 48 men with HIV who had not responded to AndroGel ® therapy reported significant improvements in sexual drive and satisfaction, erectile function, and problem assessment in men treated with Testim ® for 4 weeks compared with the group that continued using AndroGel ® ; however, no pharmacokinetic data were reported.…”

Therapeutic Potential of Testosterone Gels

“…Although from the clinical point of view, these differences are relatively small, the statistical determination of bioequivalence using 90% CIs indicated that the differences in C max and AUC 0-24h v alues observed between these two preparations were sufficient to suggest that these preparations are not bioequivalent [55,56]. Following this, Grober et al observed in 370 T-gel-treated hypogonadal men that changes in the specific gel preparation among initially unresponsive hypogonadal men is justified prior to abandoning or considering more invasive T therapy [57]. In this study, more men changed from AndroGel to Testim use than from Testim to AndroGel use.…”