Long-Term Testosterone Gel (AndroGel) Treatment Maintains Beneficial Effects on Sexual Function and Mood, Lean and Fat Mass, and Bone Mineral Density in Hypogonadal Men

Abstract

Transdermal testosterone (T) delivery represents an effective alternative to injectable androgens. We studied 163 hypogonadal men who applied 5, 7.5, or 10 g AndroGel (T gel) 1% CIII per day for up to 42 months. Efficacy data were presented in 123 subjects considered evaluable. Continuous AndroGel treatment normalized mean serum T and free T levels. Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased, mean serum estradiol/T ratio doubled, and mean serum FSH and LH levels were suppressed by T replacement. Sexual function and mood parameters improved rapidly and were maintained throughout T treatment. Lean body mass increased (P = 0.0001) and fat mass decreased (P = 0.0001), and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength. Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine (P = 0.0001) than the hip (P = 0.0004). Mild local skin irritation occurred in 12 subjects, resulting in discontinuation in only one subject. Except for the anticipated increase in hematocrit and hemoglobin, there were no clinically significant changes in blood counts or biochemistry. In three subjects with elevated serum prostate-specific antigen, prostate biopsies showed cancer. We conclude that continued application of AndroGel resulted in beneficial effects similar to those with injectables and other transdermal preparations. This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk. Thus, monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men.

Effect of testosterone supplementation on sexual functioning in aging men: a 6-month randomized controlled trial

“…24,40 Owing to the relatively high age of the participants in our study, it is likely that there were more causes for erectile dysfunction than the low-normal testosterone concentrations alone, such as neurological causes, cardiovascular diseases (arterial insufficiency, venous leak) and depression. Testosterone replacement therapy alone will not correct these problems.…”

European Consensus Statement on congenital hypogonadotropic hypogonadism—pathogenesis, diagnosis and treatment

“…Adherence to treatment is key to supporting pubertal development, sexual function and psychological health. 234 Patients with psychosexual problems, low self-esteem and distorted body image might require psychological counselling and often benefit from peer-peer support. 98,192 Bone-health concerns in patients with CHH are wellrecognized.…”

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].…”