Impact of Testosterone Solution 2% on Ejaculatory Dysfunction in Hypogonadal Men

Abstract

Introduction Hypogonadism is defined as decreased testosterone levels in men. Hypogonadism can be accompanied by erectile, orgasmic, and ejaculatory dysfunction. Aims To evaluate whether treatment with testosterone solution 2% (testosterone) could improve ejaculatory function in a cohort of hypogonadal men. Methods Sexually active, hypogonadal men at least 18 years old (total testosterone < 300 ng/dL) were randomized to receive testosterone or placebo for 12 weeks. Main Outcome Measures Effects of testosterone on primary outcomes were evaluated using the International Index of Erectile Function (IIEF) and the Men's Sexual Health Questionnaire, Ejaculatory Dysfunction, Short Form (MSHQ-EjD-SF) questionnaires. Treatment differences were calculated using analysis of covariance. Results In total, 715 men (mean age = 55 years) were randomized to placebo (n = 357) or testosterone (n = 358). Most sexually active men who reported IIEF scores had some degree of erectile dysfunction (IIEF erectile function score < 26). Although ejaculatory function score (MSHQ-EjD-SF) improved in the testosterone group compared with placebo (P < .001), improvement on the “bother” item did not reach statistical significance. Treatment-related adverse events in the testosterone group affecting at least 1% of patients were increased hematocrit, upper respiratory tract infection, arthralgia, burning sensation, fatigue, increased prostate-specific antigen, erythema, and cough. Few patients in either treatment group developed at least one adverse event leading to discontinuation (testosterone = 1.98% vs placebo = 3.09%; P = .475). Conclusion Hypogonadal men receiving testosterone solution 2% therapy experience significantly greater improvement in ejaculatory function, compared with placebo, as assessed by the MSHQ-EjD-SF. However, improvement in “bother” was not statistically different between the two groups. Testosterone therapy was generally well tolerated.

Meta-analysis of Results of Testosterone Therapy on Sexual Function Based on International Index of Erectile Function Scores

“…Both experimental and clinical studies have documented that T is profoundly involved in the regulation of the male ejaculatory reflex [50]. In line with our finding, a recent, large, placebo-controlled trial performed on more than 700 patients documented that a 2% transdermal T solution was able to improve orgasmic and ejaculatory function, although the associated bother did not improve [51].…”

Evaluation of the impact of dutasteride/tamsulosin combination therapy on libido in sexually active men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ): A post hoc analysis of a prospective randomised placebo‐controlled study

“…However, as for MSHQ total score, a minimum clinically meaningful change in ejaculation domain scores is yet to be determined. Previous studies have shown sensitivity of the total MSHQ scores to both diagnostic status and treatment conditions . The post hoc correlation analyses between sexual activity/desire and ejaculation, erection, and satisfaction domains were all in the expected direction, and in line with previously described correlations between sexual desire, erectile dysfunction, and sexual satisfaction …”

A prospective randomised placebo‐controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)

“…In contrast, the absolute changes from baseline and the differences at 12 months between placebo and the DUT‐TAM FDC therapy group, for the erection and overall satisfaction domains, were numerically very small and unlikely to be clinically relevant. Previous studies have shown the sensitivity of total MSHQ scale scores to both diagnostic status and treatment conditions . The ejaculation domain subscale of the MSHQ has shown treatment sensitivity to pharmacological and other treatments of BPH , although a minimum clinically meaningful change in ejaculation has yet to be determined.…”