Clinical experience with testosterone treatment in sildenafil non responders

Clinical experience with testosterone treatment in sildenafil non-responders

Ridwan Shabsigh, MD, Associate Professor Of Urology, Columbia University, Director, New York Center For Human Sexuality, New York, USA

Animal experiments indicate that the nitric oxide erectile pathway is testosterone dependent. Castration induces erectile dysfunction and reduction in nitric oxide synthase-stained nerves in the erectile tissue. Testosterone replenishment reverses these physiological and biochemical changes. A study presented at the 2003 AUA meeting evaluated the safety and efficacy of AndroGel® (Testosterone-gel 1%) versus Placebo-Gel in conjunction with Viagra (sildenafil) in producing an erectile response in hypogonadal men who do not respond to treatment with sildenafil alone for erectile dysfunction. The design was multicentre, double-blind study of the safety and efficacy of AndroGel® versus placebo for treatment of hypogonadal men who were non-responders to sildenafil. The selection criteria included ED for at least 3 months, stable heterosexual relationship, non-response to 100 mg of sildenafil, and low to low normal testosterone (<400ng/dL). The primary efficacy outcome measurement was the mean change from baseline in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF). Secondary outcome measures included the mean change from baseline in each of the remaining 4 domains Sexual Desire (SD), Orgasmic Function (OF), Intercourse Satisfaction (IS), Overall Satisfaction (OS) and the total sum of the IIEF. Seventy one subjects were randomised to AndroGel® + sildenafil versus placebo + sildenafil and were treated for 12 weeks. The mean age was 63 years. Testosterone replacement therapy with AndroGel® improved erectile response to sildenafil. Therefore, it may be considered for the treatment of ED in men with low to low-normal testosterone who failed prior treatment with sildenafil alone.