Largest placebo-controlled study ever conducted to measure effects of
testosterone replacement therapy offers conclusive evidence that treatment
significantly improves spontaneous erections, sexual motivation, desire and
performance
NORRISTOWN, Pa., June 10 /PRNewswire/ -- The results of the largest placebo-controlled study ever conducted to measure the benefits of testosterone replacement therapy show that men treated with Testim(TM) testosterone gel have significant improvements in measurable areas related to sexual performance, including spontaneous erections and levels of sexual motivation and desire. The study results, published in the June 2003 issue of The Journal of Clinical Endocrinology & Metabolism, further showed that treatment for hypogonadism (low testosterone) using Testim testosterone gel significantly improved sexual performance while also increasing lean body mass without exercise. This was the first large-scale study ever conducted comparing the results of testosterone replacement therapy to a placebo.
"While we have known anecdotally for years that testosterone replacement therapy has important health benefits for men with hypogonadism, this is the largest placebo-controlled study ever conducted in this field. As a result, we now have, for the first time, definitive and measurable results that demonstrate the health benefits for men with hypogonadism who are treated with Testim testosterone gel," said Christopher P. Steidle, M.D., clinical associate professor of urology, Indiana University School of Medicine at Fort Wayne, lead author of the study and one of the key investigators in the Testim development program.
The 90-day study, involving 406 hypogonadal men with a mean age of 58 years, compared the pharmacokinetics (PK) and effectiveness of Testim gel at 50 and 100 mg/day to a commercially available transdermal patch and placebo gel. Testosterone levels were measured in blood samples taken over a 24-hour period, and the effect of normalizing serum testosterone levels on body composition, sexual function, mood and bone mineral density were also assessed. Testosterone levels were normalized in significantly more patients treated with Testim gel: 80% of patients treated with 100mg Testim, and 75% of patients treated with 50mg Testim, had corrected their hypogonadal state at the end of the study, versus only 57% of patients treated with the transdermal patch and 10% of placebo-treated patients.
Patients treated with Testim also showed greater improvements in lean body mass, spontaneous erections, sexual desire and sexual performance as compared to patients treated with a transdermal patch or placebo. Testim gel was well tolerated, with very low incidence of skin irritation, while patients treated with the transdermal patch reported a high incidence of application site reactions. In addition, prostate adverse events with Testim were very low, and similar to placebo.
"In light of both the number of men affected by hypogonadism and the range of options in treating them, this study provides a critical new benchmark in helping to identify the optimal course of therapy for patients. We now have a proven effective treatment option for many of the debilitating physical and psychological symptoms associated with age-related hypogonadism, including erectile dysfunction and decreased libido, loss of muscle mass, increased body fat, and mood disturbances such as depression," Dr. Steidle added.
There are many causes of hypogonadism, including damage to the testes or pituitary gland from infection, trauma, radiation, or chemotherapy treatment, as well as congenital abnormalities such as Klinefelter Syndrome, a rare condition that occurs when a man is born with an extra X chromosome. The highest incidence of hypogonadism is seen in men over the age of 50. About 20 percent of men over 50 experience hypogonadism and its many symptoms due to a marked decline in the production of testosterone. About four to five million American men suffer from hypogonadism. Currently, only about two percent of patients with hypogonadism have been diagnosed and are receiving treatment with testosterone replacement therapy.
Testim was developed by Auxilium Pharmaceuticals and launched in the U.S. in February 2003. Testim is being marketed in the U.S. by Auxilium and its professional sales force, and is likely to be marketed in Europe and other parts of the world through partnering or licensing agreements. Testim uses a proprietary topical drug delivery technology licensed from Bentley Pharmaceuticals, Inc. (Amex: BNT).
"This study provides us with measurable data about the benefits of testosterone replacement therapy, which will, in turn, have an important impact on the treatment of men with low testosterone in the years ahead," said Gerri Henwood, president and chief executive officer of Auxilium.
Auxilium Pharmaceuticals, Inc. was founded in 1999 to develop and market pharmaceutical products that improve health and restore function as we age. Auxilium has assembled a team of leading healthcare professionals and medical advisors with superior capabilities and decades of experience in pharmaceutical R&D and commercialization. The Company is seeking to expand its portfolio by licensing additional products for development or co-promotion. For additional information, visit www.auxilium.com.
SOURCE Auxilium Pharmaceuticals, Inc.
CONTACT: Media, Jim Wetmore, Berry & Company Public Relations, +1-212-253-8881, jwetmore@berrypr.com, for Auxilium Pharmaceuticals, Inc.
© PR Newswire
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