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

• Published in: European journal of endocrinology Vol. 153; no. 2; pp. 317 - 326
• Main Authors: Kühnert, B, Byrne, M, Simoni, M, Köpcke, W, Gerss, J, Lemmnitz, G, Nieschlag, E
• Format: Journal Article
• Language: English
• Published: Colchester European Society of Endocrinology 01.08.2005; Portland Press
• Subjects: Administration, Cutaneous; Adult; Aged; Androgens - administration & dosage; Androgens - adverse effects; Androgens - blood; Biological and medical sciences; Clinical Studies; Dihydrotestosterone - blood; Endocrinopathies; Estradiol - blood; Follicle Stimulating Hormone - blood; Fundamental and applied biological sciences. Psychology; Gels; Humans; Hypogonadism - drug therapy; Luteinizing Hormone - blood; Male; Medical sciences; Middle Aged; Patient Dropouts; Prostate - anatomy & histology; Prostate-Specific Antigen - blood; Scrotum; Surveys and Questionnaires; Testosterone - administration & dosage; Testosterone - adverse effects; Testosterone - blood; Vertebrates: endocrinology; Scrotum; Testosterone; Transdermal system; Androgen; Substitution; Multicenter study; Skin; Testicular hormone; Sex steroid hormone; Endocrinology; Percutaneous route
• ISSN: 0804-4643; 1479-683X
• DOI: 10.1530/eje.1.01964

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® 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 = 54) or 5 g to non-scrotal skin (n = 56) once daily; the patch group (n = 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.