Improved Sexual Function with Testosterone Replacement Therapy in Hypogonadal Men: Real-World Data from the Testim Registry in the United States (TRiUS)

Abstract

Introduction Up to 30% of erectile dysfunction (ED) patients treated with phosphodiesterase type 5 (PDE5) inhibitors do not show improved sexual function, which may be due in part to low serum testosterone. Hypogonadal patients already receiving testosterone replacement therapy (TRT) likewise can still suffer from symptoms of sexual dysfunction. In these patient populations, augmenting with, or switching, TRT treatment may improve sexual function. Aim To determine if 12-month treatment with a testosterone gel improves sexual function in hypogonadal men, as measured by the Brief Male Sexual Function Inventory (BMSFI), and in subgroups defined by low testosterone, PDE5 inhibitor use, and prior TRT. Methods The Testim Registry in the United States (TRiUS) was a large (N = 849) multicenter registry of hypogonadal men treated with Testim (testosterone 1%) topical gel and followed for 12 months. Main Outcome Measures Data collected at suggested visits (baseline; 1, 3, 6, and 12 months) included total testosterone (TT), free testosterone (FT), BMSFI scores, physical exam, and body measurements. Results TRiUS had 271 patients with baseline testosterone and BMSFI measurements. At 12 months of TRT, TT and FT levels significantly increased from baseline (P < 0.001), with mean ± standard deviation final TT = 17.37 ± 8.61 nmol/L (500.6 ± 248.2 ng/dL) and FT = 240.1 ± 296.0 pmol/L (69.2 ± 85.3 pg/mL). The mean total BMSFI score significantly increased from baseline at 12 months (27.4 ± 10.3 to 33.8 ± 9.8, P < 0.001) and at each visit in all domains (sex drive/libido, erectile function, ejaculatory function, level of bother), overall and for all subgroups. Regression analysis indicated that increased total BMSFI score was significantly associated with increased TT levels at 6 months. Conclusions In hypogonadal patients, 12-month administration of topical testosterone gel resulted in increased TT and FT levels and significantly improved sexual function. All subgroups studied, including men taking PDE5 inhibitors for ED and those previously on TRT, demonstrated significant improvement in sexual function from baseline scores.

Late Onset Hypogonadism, Testosterone Replacement Therapy, and Sexual Health in Elderly Men

“…Testosterone replacement was well tolerated in both younger and older hypogonadal men. In this same cohort, transdermal testosterone replacement therapy was associated with improvements in multiple parameters of sexual function using the Brief Male Sexual Function Inventory [47].…”

Topical Testosterone Gel for the Treatment of Male Hypogonadism

“…9 Results from the Testim Registry in the United States (TRiUS) demonstrated that TRT in 271 hypogonadal men over 12 months resulted in increased total T (500.6 ± 248.2 ng/dL) and free T (240.1 ± 296.0 pmol/L) The Brief Male Sexual Function Inventory (BMSFI) was increased at 12 months (27.4 ± 10.3 to 33.8 ± 9.8, P , 0.001 versus baseline, ie, male sexual function such as erectile function, ejaculatory function, sexual drive and libido, were all increased as measured by BMSFI. 35 In a randomized, double-blind, placebo-controlled, multicenter study of men (234 active; 40 placebo) between the ages of 18 and 80 with androgen deficiency receiving 1.62% AndroGel™ (1.25 g, 2.5 g, 3.75 g, 5.0 g ) on shoulders and upper arms or abdomen resulted in increased T by 81.6% to 82.5% compared to placebo (range 28.6% to 37.0%). 36 1.62% AndroGel™ applied to the abdomen or upper arm and shoulder of hypogonadal men, increased serum testosterone concentration to an eugonadal range of 300-1000 ng/dL.…”

A systematic review of the correlates and management of nonpremature ejaculatory dysfunction in heterosexual men

“…Patients with PE showed the lowest (12%) and subjects with DE the highest (26%) prevalence of hypogonadism [Corona et al 2008]. Treatment of hypogonadal men with testosterone gel improved EjD score (difficulty and volume) [Khera et al 2011].…”

“…Patients with PE showed the lowest (12%) and subjects with DE the highest (26%) prevalence of hypogonadism [Corona et al 2008]. Treatment of hypogonadal men with testosterone gel improved EjD score (difficulty and volume) [Khera et al 2011].The association of metabolic syndrome and EjD was explored. In a prevalence study from Denmark evaluating the association of obesity with sexual dysfunction, obese men and those with substantially increased waist circumference are most likely to report anorgasmia [Christensen et al 2011c].…”