Evolution of delivery systems for testosterone administration

Kaufman, Joel M.

doi:10.1007/s11930-004-0025-0

Cited by 2 publications

(2 citation statements)

References 41 publications

(46 reference statements)

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“…Topical gel formulations have become the preferred means of testosterone administration offering an invisible and convenient mode of transdermal testosterone therapy [14,25]. These gels provide continuous transdermal delivery of testosterone over the 24‐hour dosing interval resulting in physiological serum levels.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men

Kaufman

Miller

Garwin

et al. 2011

The Journal of Sexual Medicine

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Introduction Male hypogonadism is a significant and growing problem that can be successfully treated with testosterone replacement therapy. A new formulation of testosterone gel (1.62%) was developed with increased viscosity, reduced volume of application, and increased skin permeation compared with other currently available testosterone gels. Aim To evaluate the efficacy and safety of titrated doses of 1.62% testosterone gel after daily application to the skin of hypogonadal men for 182 days. Methods This was a multicenter, randomized, double-blind, placebo-controlled study in hypogonadal men (234 active; 40 placebo), 18 to 80 years of age with average serum total testosterone concentrations <300 ng/dL and prostate-specific antigen <2.5 ng/mL. Topical testosterone gel (1.62%), 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel was applied once daily to either upper arms/shoulders or abdomen. Dose adjustments were made on days 14, 28, and 42. Main Outcome Measures The percentage of subjects with serum total testosterone average concentrations (Cav) within the normal range of 300–1,000 ng/dL on study days 14, 56, 112, and 182. Results Following titration, significantly (P < 0.0001) more subjects receiving active treatment had testosterone Cav values (range 81.6% to 82.5%) within the eugonadal range compared with placebo (range 28.6% to 37.0%) on all study days. The 1.62% gel was safe and well tolerated. Conclusions In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal serum testosterone levels.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men

Kaufman

Miller

Garwin

et al. 2011

The Journal of Sexual Medicine

Self Cite

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“…Hypogonadism is associated with signs and symptoms that may include reduced libido and sexual function, decreased bone mineral density and lean body mass, and depressed mood, among others, which can have significant adverse impacts on general health and quality of life . Topical testosterone gel formulations are currently the preferred method of testosterone replacement therapy (TRT) in the United States . These products provide and maintain rapid and steady eugonadal testosterone levels, when used as directed, and are generally well tolerated .…”

Section: Introductionmentioning

confidence: 99%

Testosterone Replacement with 1% Testosterone Gel and Priapism: No Definite Risk Relationship

Burnett

Kan‐Dobrosky

Miller

2013

The Journal of Sexual Medicine

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Introduction Although testosterone replacement therapy (TRT) is the preferred treatment for hypogonadism, information for patients using testosterone includes too frequent or prolonged erections as a potential side effect. Aim To assess the frequency and risk of priapism or related adverse events (AEs) in hypogonadal men treated with a 1% testosterone gel. Methods Safety and tolerability data for AndroGel 1% were assessed, including three randomized, controlled clinical trials in varying populations of hypogonadal or near hypogonadal men. Study 1 was a Phase 3 trial of AndroGel 1% 5 g, 7.5 g, or 10 g once daily for 6 months (N = 227). Study 2 was a Phase 2 trial of AndroGel 1% 7.5 g once daily titrated as needed vs. placebo for 26 weeks in men with type 2 diabetes (N = 180). Study 3 was a Phase 4 trial of AndroGel 1% 5 g once daily vs. placebo for 12 weeks in men previously unresponsive to sildenafil 100 mg monotherapy and receiving concomitant sildenafil 100 mg (N = 75). Postmarketing AndroGel pharmacovigilance reporting data from 2001 to 2011 was searched for events coded as priapism. Main Outcome Measures The incidence of priapism and/or related symptoms reported as urogenital or reproductive system AEs. Results In the 283 men exposed to AndroGel 1% over the three trials, mean exposure ranged from 84 days to 149 days. No AEs described as priapism or related symptoms were reported in the three trials. In the postmarketing data, representing 40 million units sold, eight cases described as priapism were reported. Of the six cases with accompanying data, all were judged as possibly related to AndroGel. Conclusions Safety data from the clinical trials for AndroGel 1% did not report any cases of priapism, and its incidence in the postmarketing pharmacovigilance data is extremely low, indicating a minimal risk of inducing priapism.

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Evolution of delivery systems for testosterone administration

Cited by 2 publications

References 41 publications

Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men

Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men

Testosterone Replacement with 1% Testosterone Gel and Priapism: No Definite Risk Relationship

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