Men with low testosterone (a condition known as hypogonadism) who were treated for more than 12 months with Auxilium’s Testim 1 per cent (testosterone gel) showed significant improvements in sexual function, mood, body composition (lean body mass), and bone mineral density, according to the results of a recent study involving 290 men. The study is one of the first to demonstrate that the benefits of testosterone replacement therapy are maintained following more than one year of therapy. The findings were presented today during the 4th World Congress on the Aging Male in Prague, Czech Republic.

“For men with hypogonadism who might be suffering from erectile dysfunction and low libido, the results of this study clearly demonstrate that treatment with Testim 1 per cent testosterone gel can offer significant, effective, long-term improvements in sexual function and desire,” said Christopher Steidle, clinical associate professor of urology, Indiana University School of Medicine at Fort Wayne, and one of the key investigators in the Testim 1 per cent development programme.

Following the completion of a 90-day placebo-controlled study involving 406 hypogonadal men with a mean age of 58 years, 290 hypogonadal men continued to receive treatment with Testim 1 per cent in an open-label extension study that lasted an additional 12 months. Testosterone levels were measured in blood samples taken in the morning, and the effects of normalizing testosterone on sexual function, mood, body composition, and bone mineral density were also assessed.

In the 90-day study, treatment with Testim 1 per cent resulted in rapid normalization of serum testosterone levels that continued throughout the 12-month extension study. Patients treated with Testim 1 per cent showed significant improvements in sexual desire and motivation, spontaneous erections, sexual performance, mood, and lean body mass in the 90-day study that were maintained throughout the extension study. Significant improvements in bone mineral density were also demonstrated in the long term study.

Testim 1 per cent is a novel, topical gel formulation that raises levels of testosterone in men with hypogonadism, a condition that occurs when a man’s body does not produce adequate amounts of testosterone. This condition, also known as androgen deficiency, has been estimated to occur in approximately 20 per cent of men over 50 years of age. Men with hypogonadism or androgen deficiency may suffer from a decline in energy, decreased muscle mass, an increase in abdominal fat, decreased libido, decreased sexual function, decreased frequency of erections, anemia, fatigue, depression and reduced bone density that may result in an increased risk of osteoporosis. Currently, less than five per cent of patients with hypogonadism have been diagnosed and are receiving treatment with testosterone replacement therapy.

Testim 1 per cent was developed by Auxilium Pharmaceuticals and launched in the US by its professional sales force in the first quarter of 2003. After receiving regulatory approval, Testim 1 per cent will be marketed in Canada by Bayer Inc., a division of Bayer AG and is likely to be marketed in Europe and other parts of the world through additional partnering or licensing agreements. Testim 1 per cent uses a proprietary topical drug delivery technology licensed from Bentley Pharmaceuticals, Inc.