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

  • Kaufman J
  • Miller M
  • Garwin J
 et al. 
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Abstract

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

Author-supplied keywords

  • 1.62% Testosterone Gel
  • Androgens
  • Hypogonadism
  • Pharmacodynamics
  • Pharmacokinetics
  • Testosterone replacement therapy

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Authors

  • Joel M. Kaufman

  • Michael G. Miller

  • Jeffrey L. Garwin

  • Sherahe Fitzpatrick

  • Cecilia Mcwhirter

  • John J. Brennan

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