Data show benefit of adding TRT in men with ED

Men with erectile dysfunction who do not respond to treatment with a phosphodiesterase type-5 inhibitor may benefit from the addition of a testosterone gel, according to researchers from New York-Presbyterian Hospital/Columbia University Medical Center. In related news, a form of testosterone replacement therapy that is applied to the inner cheek appears to be safe and effective.

In the Columbia study, 75 hypogonadal men were randomized to testosterone gel (Androgel) plus sildenafil citrate (Viagra) versus placebo plus sildenafil. All participants had testosterone levels in the low to low/normal range and had failed to respond to 100-mg doses of sildenafil.

Analysis of 70 men at 4 weeks found those receiving testosterone gel, 5 mg daily, in addition to sildenafil, 100 mg as needed, had a significantly improved response to treatment compared with those receiving the same dose of sildenafil plus a placebo. On the Erectile Function Domain, men receiving testosterone gel reported an average improvement of 34% from baseline, compared with 17% among those receiving placebo.

"Our data support the potential benefits of a combination therapy with testosterone gel for men with erectile dysfunction and low testosterone who find sildenafil by itself ineffective," said lead author Ridwan Shabsigh, MD, whose study appeared in the Journal of Urology (2004; 172:658-63).

In a related study, results of a phase III study showed that testosterone buccal system (Striant) is a safe and effective treatment in hypogonadal men, according to UCLA researchers.

A total of 98 hypogonadal men were enrolled the 12-week, multicenter, single-arm, open-label study. The 82 patients who completed the study protocol were treated with testosterone buccal system, 30 mg twice daily. Results showed 86.6% of patients had an average testosterone concentration within the physiologic range (3.0 to 10.5 ng/mL) at the end of 12 weeks, and average serum testosterone concentration over the 24-hour dosing period was 5.4 ng/ml.

"This study demonstrates that the buccal delivery system consistently maintains testosterone levels within the normal range without dose adjustment, and with minimal local reactions," said lead author Christina Wang, MD, of Harbor-UCLA Medical Center.

Results were published in the Journal of Clinical Endocrinology and Metabolism (2004; 89:3821-9).