John McGettigan’s research while affiliated with Quality of Life Research Center and other places

Purpose: To determine the effect of testosterone solution 2% on total testosterone level, and 2 symptoms of hypogonadism, sex drive and energy level. Materials and methods: This was a randomized, multi-center, double-blind, placebo-controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men having a testosterone level within the normal range (300-1050 ng/dL) upon treatment completion, and to assess the impact of testosterone on sex drive and energy level, measured using the Sexual Arousal, Interest, and Drive scale (SAID) and the Hypogonadism Energy Diary (HED), respectively. Males ≥18 years (N=715), with total testosterone <300 ng/dL and at least one symptom of testosterone deficiency (decreased energy, decreased sexual drive) were randomized to 60mg topical testosterone solution 2% or placebo once daily. Results: For study completers, 73% in the testosterone versus 15% in the placebo group had a testosterone level within the normal range at endpoint (p<0.001). Participants assigned testosterone showed greater baseline-to-endpoint improvement in SAID scores (low sex drive subset; p<0.001 versus placebo) and HED scores (low energy subset; p=0.02 versus placebo [not significant at pre-specified p<0.01]). No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group; the incidence of increased hematocrit was higher with testosterone (p=0.04 versus placebo). Conclusions: Once-daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on the HED though not at the pre-specified p<0.01. No new safety signals were identified.

The objective of this study was to assess drying time after application of testosterone 2% gel (Fortesta Gel, Endo Pharmaceuticals), time needed for serum total testosterone (TT) to reach the eugonadal range (⩾300 ng dl(-1)), and time to steady-state serum TT. Thirty-four men with primary or secondary hypogonadism were enrolled in the study; 31 men were included in the pharmacokinetics (PKs) population. Testosterone 2% gel (40 mg) was applied once daily in the morning to the front and inner thighs for 14 days. Median gel drying time was 2.4 min (95% confidence interval (CI), 1.7-3.4 min; n=31). Serum TT concentrations reached the target eugonadal range with a median time of 2.9 h (95% CI, 1.9-4.3 h; n=24). Median time to steady-state serum TT concentration was 1.1 days (95% CI, 0.7-3.4 days; n=31). Six patients (17.6%; n=34) reported treatment-related adverse events; all were mild. The results from this 14-day PK study in men with hypogonadism suggest that testosterone 2% gel dries, on average, in <3 min after application and that testosterone 2% gel rapidly reaches the target eugonadal range and attains steady-state serum TT concentrations in about 1 day.International Journal of Impotence Research advance online publication, 24 July 2014; doi:10.1038/ijir.2014.28.

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™ 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] ± SD) was 438.6 ± 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) (± SD) was 827.6 ± 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.