Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men.

OBJECTIVE

Testosterone replacement therapy in hypogonadal men relieves symptoms and restores serum testosterone levels to the physiological range. In this study, we assessed the safety, pharmacokinetics, and efficacy of the 2% formulation of testosterone topical solution applied daily to the axillae.

METHODS

An open-label trial was conducted in testosterone-deficient men who started on a daily dose of 60 mg of testosterone. Dose was adjusted on Days 45 and 90 when necessary to maintain serum testosterone levels within the physiological range (10·41-36·44 nmol/l) based on average serum testosterone levels on Days 15 and 60, respectively. Sexual function and mood changes were assessed by the Psychosexual Daily Questionnaire (PDQ) for the 7 days preceding visits at Days 1, 15, 60, and 120; and quality of life by SF-36 questionnaire on Days 1, 60, and 120. Safety parameters, laboratory tests, and adverse events were collected at each visit.

RESULTS

Among the Completer Set (135 study completers and 3 patients who discontinued due to adverse events), 76·1% (Days 15/16), 84·8% (Days 60/61), and 84·1% (Days 120/121) had an average total testosterone level between 10·41-36·44 nmol/l. PDQ scores increased significantly from baseline to 120 days of treatment (p < 0·0001). Significant improvement was observed in the physical (p < 0·05) and mental (p < 0·0001) components of the SF-36 after 120 days of treatment. Adverse events reported in >2% of the 155 subjects who received ≥ 1 dose were application site irritation (7·1%), application site erythema (5·2%), headache (5·2%), increased hematocrit (3.9%), nasopharyngitis (3·9%), diarrhea (2·6%), and vomiting (2·6%).

CONCLUSIONS

These results indicate that once-daily application of the testosterone topical solution 2% to the axillae is a safe and effective treatment for androgen replacement in hypogonadal men.