AA2500 Testosterone Gel Normalizes Androgen Levels in Aging Males with Improvements in Body Composition and Sexual Function

Abstract

Testosterone replacement in hypogonadal men improves body composition, mood, and sexual functioning. In this 90-d study, we compared the pharmacokinetics and treatment effectiveness of a topical testosterone gel (AA2500) at two concentrations, 50 mg/d and 100 mg/d, to a testosterone patch and placebo gel in 406 hypogonadal men. Pharmacokinetic profiles were obtained, body composition was measured, and mood and sexual function were monitored. AA2500 treatments resulted in dose-dependent improvements in all pharmacokinetic parameters, compared with testosterone patch and placebo. Mean average concentrations at d 90 T were 13.8, 17.1, 11.9, and 7.3 nmol/liter for 50 mg/d AA2500, 100 mg/d AA2500, testosterone patch, and placebo, respectively. At d 90, the 100 mg/d AA2500 treatment improved lean body mass by 1.7 kg and percentage of body fat by 1.2% to a significantly greater degree than either control treatment. Significant improvements in spontaneous erections, sexual desire, and sexual motivation were also evidenced with the 100 mg/d AA2500 dose in comparison with placebo. Testosterone gel was well tolerated; however, the testosterone patch resulted in a high rate of application site reactions. Overall, AA2500 is an effective, well tolerated treatment for hypogonadism.

Testosterone and Erectile Function: From Basic Research to a New Clinical Paradigm for Managing Men with Androgen Insufficiency and Erectile Dysfunction

“…Hormonal agents [82,83] include testosterone, DHEA, clomiphene citrate, aromatase inhibitors, 5-alpha reductase inhibitors, dopamine agonists, and thyroid therapies [82,83]. For androgen insufficiency, androgen delivery systems, listed chronologically, include oral testosterone [137], intramuscular depot injections [138], scrotal transdermal patch systems [139], nongenital skin transdermal patch systems [140], hydroalcoholic testosterone gels, [141,142], adhesive buccal tablets [143], and, recently, longacting intramuscular depot injections [144]. Nonhormonal treatments include vasodilators such as PDE5 inhibitors and intracavernosal/intraurethral agents [145].…”

Testosterone therapy increases sexual desire in ageing men with low–normal testosterone levels and symptoms of androgen deficiency

“…5 In that study a comparative group receiving transdermal testosterone (2 Â 2.5 mg patches per day) also showed an improvement in sexual desire but this was not different to the change seen in the placebo group. We are not aware, however, of other placebo-controlled trials that have shown an improvement in sexual desire in ageing men with testosterone levels in the low-normal range treated with physiological testosterone therapy.…”

“…The relationship between TT and obesity is consistent with a previous study of testosterone therapy in ageing men whereby the (mean) BMI of men with (mean) baseline testosterone levels of 8 nM was 30 kg m À2 . 5 A limitation of the current study is the number of subjects completing the active arm of the study as a result of a higher than expected dropout rate in the men receiving testosterone. The reason for subject dropout in this group was mostly related to patch intolerance (manifesting as a skin reaction confirmed by the study investigators) suggesting that this rather than a perceived lack of benefit was the reason for discontinuation from the study.…”

“…1 Placebo-controlled trial data however are equivocal or, at best, report modest beneficial effects on these end points. [2][3][4][5] While reductions in sexual desire and function are frequent accompaniments of male ageing, 6 the extent to which they correlate with testosterone levels is not well defined [7][8][9] particularly when testosterone levels remain within the normal young adult range, 10 and the increasing prevalence of erectile dysfunction in older men predominantly relates to neurovascular disease. 11,12 Most studies of testosterone therapy in older men that have assessed sexual function have failed to demonstrate significant improvement, 2 especially when baseline serum testosterone levels are in the low-normal or normal range.…”

“…11,12 Most studies of testosterone therapy in older men that have assessed sexual function have failed to demonstrate significant improvement, 2 especially when baseline serum testosterone levels are in the low-normal or normal range. 3 To date only three randomized controlled trials of androgen therapy in ageing men have studied a cohort selected for the presence of symptoms known to be associated with hypoandrogenism, 5,13,14 and in these studies only one 5 or two 13,14 positive symptoms (but not necessarily relating to sexual dysfunction) were required for enrolment.…”