A Novel Testosterone 2% Gel for the Treatment of Hypogonadal Males

Abstract

Testosterone replacement therapy (TRT) can improve the symptoms, signs, and well being of hypogonadal men by restoring serum testosterone concentrations to physiologic levels. This multicenter, open-label noncomparative trial of men with hypogonadism evaluated the pharmacokinetic profile and safety of a novel testosterone 2% gel (Fortesta TM Gel), administered once daily to the front and inner thighs at starting doses of 40 mg/d. The metered-dose delivery system allowed dose adjustments in 10-mg increments between 10 and 70 mg/d. Of the 149 patients enrolled, 138 patients (92.6%) completed the study and 129 patients (86.6%) were included in the efficacy analysis. On day 90, mean testosterone concentration (C avg [0-24 hours] 6 SD) was 438.6 6 162.5 ng/dL. Overall, 100 (77.5%) patients achieved serum total testosterone concentrations within the normal physiologic range ($300 and #1140 ng/dL). On day 90, mean testosterone C max (6SD) was 827.6 6 356.5 ng/dL. On day 90, a total of 122 patients (94.6%) had C max levels of 1500 ng/dL or less and 2 patients (1.6%) had values between 1800 and 2500 ng/dL. Similar results for C avg (0-24 hours) and C max were observed on day 35. All enrolled patients were included in the safety analysis. Testosterone 2% gel was generally well tolerated, with the most common adverse events (AE) being mild and moderate skin reactions. There were no serious AEs related to testosterone 2% gel. Once-daily testosterone 2% gel restored levels of testosterone in more than 75% of patients, with low risk of supraphysiologic testosterone levels. Patients may find this a suitable option for TRT because of its application site and low volume.

An update on male hypogonadism therapy

“…In the US, the gel formulations that are currently available are 1, 1.62 and 2% testosterone gel. A 2% hydro-alcoholic testosterone gel that shows similar pharmacokinetics as other gels is available [121] as is another 2% testosterone gel that does not contain alcohol and is applied to the axilla using an applicator. The pharmacokinetics data of the testosterone gel applied to the axillae are comparable to the other testosterone gels [122].…”

Pharmacology of testosterone replacement therapy preparations

“…The effects of Fortesta ® 2% gel on serum testosterone levels was evaluated in a multicenter, open-label study of 129 men with hypogonadism (32). The subjects applied Fortesta ® 2% gel initially at 40 mg/day to their front and inner thighs for 90 days.…”

Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone

“…Their benefits include easy application with generally good tolerability and dosing flexibility, and T assays to check response to therapy can be administered as early as 1 week after initiation (Bhasin et al, 2010). Results of various TTA clinical trials indicate that many patients require doses higher than the labeled recommended starting dose (RSD) to attain and maintain normal testosterone levels (Dobs et al, 2012;Kaufman et al, 2011;Steidle et al, 2003;Wang et al, 2000;Wang et al, 2011). A recent retrospective administrative claims data study reported that after initiation of therapy, the dose utilized by patients increased until maintenance dose was achieved in Month 4 (Kaltenboeck et al, 2013).…”