Testosterone therapy demonstrates positive responses

October 15, 2009

An investigational formulation of testosterone solution 2% (Axiron) is effective in men with hypogonadism, according to recently released results of a phase III trial examining 155 men across six countries and 26 sites.

An investigational formulation of testosterone solution 2% (Axiron) is effective in men with hypogonadism, according to recently released results of a phase III trial examining 155 men across six countries and 26 sites.

The study met its primary endpoint by demonstrating that after 4 months of treatment with the liquid solution, 84% of subjects achieved average blood levels of testosterone within the normal range, significantly exceeding the requirement of 75% that was agreed upon with the FDA.

After 2 weeks of treatment, 76% of subjects had average blood levels of testosterone within the normal range. The average testosterone level for the responder group after 120 days of treatment was 504 ng/dL. The average baseline testosterone level in subjects prior to treatment was 190 ng/dL.

Four different dose levels of the solution were tested, and the trial demonstrated that the optimum dose for 75% of subjects was 60 mg per day, equivalent to one single application of the solution to each armpit.

Analysis of mood, sexual desire, sexual activity, and sexual performance before and after 4 months of treatment showed significant improvement from baseline across all measures. There were no serious adverse events.

"In terms of the proportion of responders to testosterone replacement using Axiron, the pharmacokinetic parameters and the response from this multicenter clinical trial, the results are very exciting and precisely what we had hoped to see," said lead investigator Christina Wang, MD, of Los Angeles Biomedical Research Institute and the David Geffen School of Medicine at UCLA.