A pilot study to evaluate the effects of vardenafil on sexual distress in men with obesity.

There are no interventional studies on the impact of sexual distress (SD) in men with obesity. We investigated the effects of vardenafil (VAR) on SD in middle-aged (mean age 49 ± 8), healthy, obese men in the absence of premature ejaculation, ED or hypogonadism. After a 4-week run-in period, 20 men with high body mass index (BMI=40 ± 8) and SD at the Sexual Distress Esteem Questionnaire-Male (mean score 65 ± 20 AU) were randomized to receive either VAR 10 mg on demand (N=10) or matched-placebo (PLB, N=10). Primary endpoints were variations from baseline in the intravaginal ejaculatory latency time (IELT) measured by the stopwatch technique; secondary endpoints were variations from baseline in Self-Esteem and Relationship (SEAR) and Male Sexual Health Questionnaire-Ejaculatory domain (MSHQ-EjD) scores. VAR significantly improved IELT (P<0.0001), as well as SEAR (P<0.001) and MSHQ-EjD (P<0.005) scores, whereas no changes were observed after PLB. Interestingly, an inverse relationship between BMI and IELT was found in all the men studied (r(2)=0.37, P<0.001). SD in healthy obese men seems to be correlated mainly with inadequate ejaculatory control, especially in men with higher BMI. Our preliminary results suggest that treatment with VAR may improve ejaculatory control, thus ameliorating self-esteem and sexual performance in men with obesity.