Efficacy and Safety of a New Topical Testosterone Replacement Gel Therapy for the Treatment of Male Hypogonadism

A new 2% testosterone gel formulation: a comparison with currently available topical preparations

“…C max ) outside the eugonadal range are short, isolated and sporadic, which infrequently affect testosterone/dihydrotestosterone ratios (T/DHT) (Swerdloff et al ., ; Steidle et al ., ; Wang et al ., ). Generally, these fluctuations are noted while optimising the dose, and the ability of the titration regimen to consistently preclude or minimize exposure to supra‐physiological testosterone excursions (Kaufman et al ., ; Cunningham et al ., ). In other instances, such isolated peak fluctuations are often explainable by sample errors, sample site contamination, and are not considered to be associated with unfavourable side effects.…”

“…In‐line with this, a meticulous dose titration scheme was designed for Testavan in the pivotal study (study 000127). The focus was also on maintaining the normal physiological range for testosterone and DHT and reduces the instances of supraphysiological testosterone levels (Cunningham et al ., ).…”

“…Treatment with Testavan caused a significant improvement in International Index of Erectile Function (IIEF) and Multidimensional Assessment of Fatigue (MAF) scores, and Short Form 12 (SF‐12) Health Survey total scores following a three‐month treatment period in phase II and III studies. The benefit was sustained for a continued treatment for up to six months (Efros et al ., ; Belkoff et al ., ; Cunningham et al ., ). This is comparable with that reported with Androgel ® (Pexman‐Fieth et al ., ; Snyder et al ., ), Axiron ® (Burns et al ., ), Testim ® (Steidle et al ., ) and Tostrex ® (Jones et al ., )…”

“…This formulation can be applied using a metered dose dispenser and a cap applicator, which limits/eliminates the use of hands, thereby lowering the risk of secondary exposure. This was evident in the phase III study wherein all patients were either satisfied or very satisfied with the cap applicator, with 87% of patients feeling that using the cap applicator reduced the risk of secondary exposure (Cunningham et al ., ). This dispensing mode is not available for any of the approved testosterone gel formulation.…”

“…For Axiron ® and Androgel ® , the responder rates were 84.1% (Wang et al ., ) and 82.1% (Kaufman et al ., ), respectively. For Testavan, the responder was >75% in the pivotal study (Cunningham et al ., ), and >82% (Belkoff et al ., ) in two supportive studies. The responder rates at multiple time points for various testosterone gels are presented in Table .…”