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Title: Men with Borderline Low and Low Baseline Testosterone Benefit Equally from Testosterone Gel (Androgel): Presented at ENDO

"Men with Borderline Low and Low Baseline Testosterone Benefit Equally from Testosterone Gel (Androgel): Presented at ENDO"

By Maggie Schwarz PHILADELPHIA, PA -- June 23, 2003 -- Transdermal testosterone replacement gel (Androgel) improves sexual function, body composition and bone mineral density in men with borderline low testosterone levels almost equal as in men with pretreatment testosterone levels below the normal, according to a study reported here June 20th at the Endocrine Society's 85th Annual Meeting. "Our results show that treatment can benefit men with testosterone levels in the borderline low range," said Christina Wang, MD, an endocrinologist at University of California, Los Angeles General Clinical Research Center, who conducted her research with investigators from 15 participating centers across the U.S. Dr. Wang and her associates suspected that men with persistently low blood testosterone levels would respond better to transdermal replacement testosterone than those with variably low baseline levels. This proved not to be the case, according to their findings. "Health improvements in men with pretreatment borderline low levels were comparable to those in men with consistently low testosterone. Furthermore, the study demonstrates testosterone supplementation is safe and effective in both patient groups over a 2-year period," said Dr. Wang. In the trial enrolled 87 hypogonadal men with serum testosterone levels consistently lower than 300 ng/dL (mean 221 ng/dL) and 34 hypogonadal men with levels lower than 300 ng/dL at initial screening but higher than 300 ng/dL just prior to initiating treatment. Their average age was 51 years. These men received continuous transdermal testosterone replacement for up to 36 months. Initially, they were treated with a 1% testosterone gel (5 g or 10 g) or patch (5 mg) per day. Some men received a dose adjustment of 7.5 g per day with the gel at 3 months to maintain testosterone levels in a normal range. After 6 months, all men received the gel, with dose adjustments allowed throughout treatment depending on symptoms. Results indicate that in men with initially low testosterone levels, repeat testosterone levels did not significantly predict a positive responsiveness of sexual function, body composition and bone mineral density to long-term testosterone treatment. While Dr. Wang believes treatment with testosterone should be reserved for men with laboratory evidence of hormonal deficiency, she asserts that patients with partial androgen deficiency may benefit from treatment as well. The study was supported by UNIMED-Solvay. [Study title: Does Pretreatment Serum Testosterone Affect Responsiveness to Long Term Transdermal Testosterone Gel (Androgel) Treatment in Hypogonadal Men? Abstract P2-166]

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