Adjunctive use of AndroGel (testosterone gel) with sildenafil to treat erectile dysfunction in men with acquired androgen deficiency syndrome after failure using sildenafil alone.

Objectives: To evaluate whether combination therapy with testosterone gel (T-gel) and sildenafil citrate is effective in achieving adequate potency in subjects with low-normal serum testosterone levels in whom sildenafil alone has failed.

Methods: From July 2000 to June 2001, we evaluated 90 men (aged 32 to 72 years) in whom 3 months of sildenafil therapy at the maximal recommended dose (100 mg) with at least three attempts at intercourse during the 3-month period had failed. Of these, 24 men had testosterone levels less than 400 ng/dL (range 92 to 365, mean 231.4) and were subsequently started on 1% T-gel monotherapy (AndroGel, 5 g daily). After 4 weeks of T-gel alone (week 4), sildenafil citrate (Viagra, 100 mg) was added to the treatment regimen for an additional 12 weeks (through week 16). Potency was defined as the ability to have at least one episode of satisfactory intercourse during the treatment period.

Results: All the men had normalized serum testosterone levels after 4 weeks of T-gel monotherapy (range 424 to 596 ng/dL, mean 525). However, none of the men regained potency. At week 16, almost all (22 of 24, 92%) of the men reported improved potency with combination therapy. Improvement in erection quality was also observed.

Conclusions: The results of this study support the use of T-gel with sildenafil citrate in men with low-normal serum testosterone levels in whom sildenafil alone fails. It also underscores the numbers of men with low to low-normal testosterone levels who would benefit from testosterone screening when evaluated for erectile dysfunction.