Testosterone substitution with a new transdermal, hydroalcoholic gel applied to scrotal or non-scrotal skin: a multicentre trial

Abstract

Objective: Testosterone-containing gels have improved testosterone substitution therapy, but they are associated with the risk of interpersonal transfer. Therefore, we tested a new hydroalcoholic 2.5% testosterone gel (TGW), which was removed by washing 10 min after administration. Design: The gel was applied to scrotal or non-scrotal skin in comparison to two 2.5 mg Androderm w patches in a randomised, three-arm, parallel-group, controlled multicentre trial over a period of 24 weeks. We included symptomatic hypogonadal men whose morning testosterone levels were , 10 nmol/l. Either 1 g TGW was applied to scrotal skin (n ¼ 54) or 5 g to non-scrotal skin (n ¼ 56) once daily; the patch group (n ¼ 52) applied two patches/day. Dose titration was allowed. Results: Whereas serum testosterone levels and the pre-post changes of the areas under the curve of testosterone and free testosterone between weeks 0 and 24 indicated equivalent treatment success for the patch and scrotal groups, the dermal gel group was significantly superior to the other two groups. Questionnaires on sexual function, mood and quality of life did not differ significantly between study groups, nor were prostate volume, prostate-specific antigen (PSA) levels and prostate symptoms different. However, tolerability was much better in the gel groups than the patch group. Conclusion: Efficacy, safety and tolerability suggest TGW as a favourable treatment for hypogonadal patients.

The benefits and risks of testosterone replacement therapy: a review

“…285,286 In addition, no effect was found of testosterone replacement therapy on PSA levels [287][288][289] and the change in PSA were not influenced by the mode of testosterone replacement therapy, patient age, or baseline levels of PSA or testosterone. 290 The online prostate cancer risk calculator is one of the most commonly used tools to assist the clinician in assessing the risk of prostate cancer. [291][292][293] All men who present for TRT should undergo prostate biopsy if they have abnormal PSA level or abnormal result on digital rectal examination with low threshold to do or repeat prostate biopsy if the PSA level or digital rectal exam changes.…”

Safety and efficacy of testosterone gel in the treatment of male hypogonadism

“…30 In a short-term study with Testim, Loizides and colleagues 54 showed that measures of positive and negative mood improved significantly, beginning with the first week of therapy and reaching a maximal response at the second week. Kuhnert and colleagues 28 have reported similar findings.…”

“…The dose-dependent improvements in all pharmacokinetic profiles of testosterone gel in comparison to testosterone patch have been replicated in other studies. [28][29][30][31] In a open-label crossover study of 30 hypogonadal men with human immunodeficiency virus (HIV), Scott and colleagues 32 compared the response between weekly intramuscular (IM) testosterone (100-200 mg/week) and 1% Androgel (5-10 g/day) for eight weeks. Peak levels of serum-free testosterone concentrations were significantly greater after IM testosterone (42 pg/mL) than after Androgel (23 pg/mL) (P  0.001).…”

“…Mean IPSS scores were not increased from baseline. Although short-term studies 27,28,42 using Androgel or Testim have reported no cases of prostate cancer, one year 30 and three year 26 extensions of these studies have documented prostate cancer in a small number of subjects. In both short and long-term testosterone gel studies, PSA elevations of 4 ng/mL or greater have occurred only in a minority of individuals and many of them have either had normal PSA values on repeat measurements or normalization of PSA on discontinuation of testosterone or negative biopsies (in subjects who had persistent elevations in PSA despite treatment discontinuation).…”

Topical Testosterone Gel for the Treatment of Male Hypogonadism

“…39 Transdermal patches usually deliver 5-6 mg of T daily and provide relatively steady state T levels at low to midnormal ranges. 13,15,16,31,40,60,61,88 Higher T level can be achieved by applying more than one transdermal patch. Long term use of patches for 3-10 years has been shown to be effective in maintaining SF, bone density and muscle mass in both young and elderly hypogonadal men.…”