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−1 and 10.4 pg ml−1, respectively. Total testosterone levels were below 300 ng dl−1 in 58% of these patients. Following a change to Testim, mean total and free testosterone levels increased to 484 ng dl−1 (P<0.001) and 14.6 pg ml−1 (P=0.01), respectively. Total testosterone levels remained below 300 ng dl−1 in only 17% of these patients. Among patients initially treated with Testim, the mean total and free testosterone levels were 544 ng dl−1 and 18.0 pg ml−1, respectively. Total testosterone levels were below 300 ng dl−1 in 15% of men. Following testosterone gel change to Androgel, mean total and free testosterone levels were 522 ng dl−1 (P=0.7) and 16.1 pg ml−1 (P=0.6), respectively. Total testosterone levels remained below 300 ng dl−1 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.
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Araujo AB, O'Donnell AB, Brambilla DJ, Simpson WB, Longcope C, Matsumoto AM et al. Prevalence and incidence of androgen deficiency in middle-aged and older men: estimates from the Massachusetts male aging study. J Clin Endocrinol Metab 2004; 89: 5920–5926.
Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C . Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract 2006; 60: 762–769.
Extent Nature of Testosterone Use (News Release). IMS Health: Fairfield, CN, 2006.
McNicholas TA, Dean JD, Mulder H, Carnegie C, Jones NA . A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function. BJU Int 2003; 91: 69–74.
Bouloux P . Testim 1% testosterone gel for the treatment of male hypogonadism. Clin Ther 2005; 27: 286–298.
Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM et al. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab 2000; 85: 4500–4510.
Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab 2004; 89: 2085–2098.
Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guidelines. J Clin Endocrinol Metab 2006; 91: 1995–2010; http://www.endo-society.org/publications/guidelines/final/upload/AndrogensMenGuideline053006.pdf.
Morley JE, Charlton E, Patrick P, Kaiser FE, Cadeau P, McCready D et al. Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism 2000; 49: 1239–1242.
SPSS Statistical Software for Windows, Version 14 2007, www.spss.com.
Mazer N, Bell D, Wu J, Fischer J, Cosgrove M, Eilers B . Comparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men. J Sex Med 2005; 2: 213–226.
Steidle C, Witt MA, Matrisciano J, Block JE . Sexual functioning and satisfaction in nonresponders to testosterone gel: potential effectiveness of retreatment in hypogonadal males. Clin Cornerstone 2005; 7 (Suppl 4): S20–S25.
Schrader S, Mills A, Scheperle M, Block JE . Improvement in sexual functioning and satisfaction in nonresponders to testosterone gel: clinical effectiveness in hypogonadal, HIV-positive males. Clin Cornerstone 2005; 7 (Suppl 4): S26–S31.
Marbury T, Hamill E, Bachand R, Sebree T, Smith T . Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, testim, compared to AndroGel. Biopharm Drug Dispos 2003; 24: 115–120.
We acknowledge the following potential conflicts of interest: Dr Ethan D Grober: Speaker—Auxilium, Dr Mohit Khera: Investigator—Auxilium, Author—Solvay, Dr Larry I Lipshultz: Consultant, Speaker, Author—Solvay, Consultant, Speaker, Investigator—Auxilium.
Conflict of interest
There are no sources of funding directly related to this research to disclose.
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Grober, E., Khera, M., Soni, S. et al. Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men. Int J Impot Res 20, 213–217 (2008). https://doi.org/10.1038/sj.ijir.3901618
- testosterone replacement therapy
- testosterone gel
Response to: Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men
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