Novel testosterone gel improves aging males' symptoms in patients with late-onset hypogonadism: Active control equivalence, randomized, double-blind, crossover pilot study

Abstract

ABSTRACT Introduction The standard treatment for late-onset hypogonadism (LOH) is testosterone replacement therapy (TRT). In Japan, testosterone enanthate intramuscular injection is recommended for LOH. But it needs regular clinic visits every 2-3 week, and it elicit pain. The 2% testosterone gel (AndroForte2®) is available for treatment LOH. Because of imported drug, AndroForte2® (AF2) is expensive. We have created a 2 % novel testosterone gel (NTG). Objective We hypothesized that our NTG improves Aging males' symptoms (AMS) scores, and serum testosterone in patients with LOH. Methods In this active control equivalence, randomized, double-blind, crossover study, it enrolled that were men with low serum free-testosterone (defined as below 11.8pg/mL), and symptoms of androgen deficiency (defined as AMS scores more than 27). The patients were randomly divided into two groups (A group, men receiving the NTG first; and B group, men receiving the AF2 first). Men with LOH received 2% AF2 for 28 days or 2% NTG for another 28 days separated by a 14-day washout period. The AMS score and serum hormonal data, and adverse events were assessed. Results Twenty-three patients aged 42–71 years old were enrolled in and concluded the study with no adverse events experienced. Serum testosterone and free-testosterone concentrations were significantly higher with NTG and AF2. And more, both concentrations were significantly higher in NTG than AF2. The AMS total score, physical subscore, mental subscore, and sexual subscore were significantly improved with NTG, but not significant with AF2. Conclusions This is the first study to show that our NTG may not be effective for improvement serum testosterone level but also for physical, mental, and sexual symptoms in patient with LOH. Disclosure Work supported by industry: no.