Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim™, compared to AndroGel<sup>®</sup>

Marbury, Thomas; Hamill, E.; Bachand, Romeo T.; Sebree, Terri; Smith, Ted

doi:10.1002/bdd.345

Cited by 69 publications

(42 citation statements)

References 5 publications

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“…Randomized, crossover studies have demonstrated that peak serum concentrations of total testosterone, free testosterone and dihydrotestosterone are significantly greater following dose equivalent application of Testim gel compared to Androgel. 5,14 The enhanced absorption of Testim is attributed to pentadecalactone, an emollient specific to Testim, which also accounts for the unique scent of the gel. 14 Reflecting this underlying physiology, the majority (92%) of men switched from Androgel to Testim secondary to persistent hypogonadal symptoms or subtherapeutic serum testosterone levels.…”

Section: Discussionmentioning

confidence: 99%

“…5,14 The enhanced absorption of Testim is attributed to pentadecalactone, an emollient specific to Testim, which also accounts for the unique scent of the gel. 14 Reflecting this underlying physiology, the majority (92%) of men switched from Androgel to Testim secondary to persistent hypogonadal symptoms or subtherapeutic serum testosterone levels. In contrast, the leading indication for substituting Androgel for Testim was not due to a subtherapeutic clinical response or poor drug absorption, but secondary to specific properties of the gel (that is scent of the gel, skin residue or reaction).…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2007

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

et al. 2007

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“…Subcutaneous gels have become very popular in the United States as they provide physiological levels of circulating testosterone with minimal inconvenience, and only a small amount of skin irritation [107,108]. Buccal administration of testosterone has to date been poorly accepted by patients [109].…”

Section: Testosterone Therapiesmentioning

confidence: 99%

Andropause: Is the Emperor Wearing Any Clothes?

Tariq

Haren

Kim

et al. 2005

Rev Endocr Metab Disord

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“…A randomized, crossover study was performed by Marbury and colleagues 33 to compare the pharmacokinetic profiles of Testim and Androgel. Twenty-nine hypogonadal subjects received a single dose (5 g) of each formulation seven days apart.…”

Section: Dovepressmentioning

confidence: 99%

“…The enhanced absorption of Testim is attributed to pentadecalactone, an emollient specific to Testim, which also accounts for the unique scent of the gel. 33 In summary, although Testim appears to have a greater bioavailability than Androgel, this advantage is at the expense of undesirable physical properties such as its stickiness and smell. An easy option for Androgel users not achieving adequate serum testosterone levels would be to increase the dose rather than switching brands.…”

Section: Androgel Versus Testimmentioning

confidence: 99%

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

Lakshman¹,

Basaria²

2009

CIA

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Transdermal testosterone gels were first introduced in the US in 2000. Since then, they have emerged as a favorable mode of testosterone substitution. Serum testosterone levels reach a steady-state in the first 24 hours of application and remain in the normal range for the duration of the application. This pharmacokinetic profile is comparable to that of testosterone patch but superior to injectable testosterone esters that are associated with peaks and troughs with each dose. Testosterone gels are as efficacious as patches and injectable forms in their effects on sexual function and mood. Anticipated increases in prostate-specific antigen with testosterone therapy are not significantly different with testosterone gels, and the risk of polycythemia is lower than injectable modalities. Application site reactions, a major drawback of testosterone patches, occur less frequently with testosterone gels. However, inter-personal transfer is a concern if appropriate precautions are not taken. Superior tolerability and dose flexibility make testosterone gel highly desirable over other modalities of testosterone replacement. Androgel and Testim, the two currently available testosterone gel products in the US, have certain brandspecific properties that clinicians may consider prior to prescribing. Keywords: testosterone gel, Androgel, Testim, hypogonadism Physiology of hypothalamic-pituitary-gonadal axisTesticular function is dependent on the hypothalamic secretion of gonadotropin-releasing hormone (GnRH) which in turn stimulates the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the pituitary to act on the testis. This results in spermatogenesis and testosterone production via stimulation of seminiferous tubules and Sertoli cells, and Leydig cells, respectively. Testosterone is secreted at adult levels during three periods of male life: transient surge during the first trimester of intrauterine life, perinatal surge during early neonatal life, and continually after puberty to maintain androgenization. Testosterone exerts negative feedback both at the level of the hypothalamus and the pituitary gland. Additionaly, sertoli cells produce inhibin that exerts a negative feedback on FSH secretion. Diagnosis of androgen deficiencyThe estimates of the prevalence of androgen deficiency, defined solely in terms of serum testosterone concentrations below the lower limit of the normal range for healthy young men, vary greatly among different studies. Longitudinal data from the Massachusetts Male Aging Study (MMAS) indicate that the prevalence of symptomatic androgen deficiency (Total testosterone 300 ng/dL) in men aged between 40-69 years is between 6% and 12%.

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Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim™, compared to AndroGel^®

Cited by 69 publications

References 5 publications

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

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

Andropause: Is the Emperor Wearing Any Clothes?

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

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Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim™, compared to AndroGel®

Cited by 69 publications

References 5 publications

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

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

Andropause: Is the Emperor Wearing Any Clothes?

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

Contact Info

Product

Resources

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Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim™, compared to AndroGel^®