Restorative Increases in Serum Testosterone Levels Are Significantly Correlated to Improvements in Sexual Functioning

Abstract

It is recognized that testosterone (T) levels decrease in men with age, as does sexual function. We hypothesize that T supplementation in hypogonadal men with sexual dysfunction will restore certain elements of sexual function. Hypogonadal male subjects (total T ≤ 300 ng/dL, n = 406, mean age 58 years) reporting one or more symptoms of low testosterone were randomized to T gel (50 mg/d and 100 mg/d), T patch, or placebo. Twenty‐four‐hour pharmacokinetic profiles for T were obtained. The 3 primary end points evaluated at 30 and 90 days posttreatment included a significant change in the frequency of intercourse and nighttime erections per 7‐day week as well as a change in sexual desire measured on a Likert‐type scale and calculated as a mean daily score. At day 30, a significant increase from baseline in sexual desire was noted for those on 100 mg/d T gel compared with those on 50 mg/d T gel, T patch, or placebo (1.2 vs 0.4, 0.7, and 0.4, respectively). A significant increase from baseline in the frequency of nighttime erections was also noted for those on 100 mg/d T gel compared with those on 50 mg/d T gel or placebo (51% of subjects in the 100 mg/d T gel group had an increase in frequency vs 30% for the 50 mg/d T gel group and 26% in the placebo group). Finally, a significant increase from baseline in the frequency of intercourse was evidenced for those on 100 mg/d T gel compared with those on T patch or placebo (39% of subjects in the 100 mg/d T gel group had an increase in frequency vs 21% for the T patch group and 24% in the placebo group). Similar results were seen for 100 mg/d T gel at day 90 for sexual desire and nighttime erections vs placebo. These data demonstrate a clear relationship between restoring serum T concentrations and improvement in certain parameters of sexual function. We propose that threshold T levels are needed in order to significantly affect improvements in sexual functioning.

Testosterone replacement therapy for male hypogonadism: Part III. Pharmacologic and clinical profiles, monitoring, safety issues, and potential future agents

“…In one study, threshold serum T values (C avg ) were identified above which significant improvements were noted: 500 ng/dl for the frequency of sexual intercourse and 600 ng/dl for self-rated sexual desire (Figure 1). 10 The frequency of night time erections rose significantly even when serum T levels were low-normal (C avg ¼ 400 ng/dl), suggesting that this androgenic effect may be among the earliest to be observed during TRT.…”

“…6 Application-site reactions represent the most frequent complaints with both T gels, occurring in up to 5% of patients. 6,7 With regard to prostate safety, 2.8-18.8% of 106 men receiving T gel (AndroGel) 50-100 mg experienced prostate enlargement or elevation in PSA 6 Additional study findings on the effects of T gels on PSA levels 10,12 are shown in Table 1.…”

The role for intramuscular testosterone injection in the gel era

“…The value for restoring sexual functions in hypogonadal men receiving treatment with testosterone gel is well documented [5,6,[8][9][10]. A recent study shows the adjunctive role of testosterone gel with sildenafil [11].…”

The role of testosterone in erectile function and dysfunction

“…Recently, in a large cohort of 406 men (mean age 58 years and total testosterone < or = 300 ng/dL) a clear relationship was reported between restoring serum testosterone to the normal range and improvement of certain parameters of sexual functioning, such as sexual desire, nocturnal erections and frequency of intercourse [20]. Remarkably, in this study the results of testosterone administration with a 100 mg gel were superior to those of 50 mg gel or a testosterone patch, raising the issue of threshold values of testosterone for sexual functioning in elderly men.…”