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

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 <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.

Phase 1 pharmacokinetics and phase 3 efficacy of testosterone nasal gel in subjects with seasonal allergies

“…11,24,25,26 Fifty-eight patients with prior medical history of AR were Baseline characteristics and treatment outcomes for AR and non-AR patients completing the 90-day treatment period are very similar (Table 6). Hypogonadal patients with AR had a mean starting testosterone level of 250 ng/dL compared to 229 for non-AR patients.…”

Update on Testosterone Replacement Therapy in Hypogonadal Men

“…Feneley also looked at how different preparations of TRT affected PSA and found no difference between oral, intramuscular, or topical preparations [19•]. Further, Kaufman found that supraphysiologic levels of testosterone in eugonadal men did not affect PSA [61]. Finally, Salonia found that even large doses of DHT did not alter PSA, prostate volume, or IPSS [16].…”

Topical Testosterone Gel for the Treatment of Male Hypogonadism

“…35 In a randomized, double-blind, placebo-controlled, multicenter study of men (234 active; 40 placebo) between the ages of 18 and 80 with androgen deficiency receiving 1.62% AndroGel™ (1.25 g, 2.5 g, 3.75 g, 5.0 g ) on shoulders and upper arms or abdomen resulted in increased T by 81.6% to 82.5% compared to placebo (range 28.6% to 37.0%). 36 1.62% AndroGel™ applied to the abdomen or upper arm and shoulder of hypogonadal men, increased serum testosterone concentration to an eugonadal range of 300-1000 ng/dL. However, if applied to the abdomen the bioavailability of T concentration was only 30%-40%.…”