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| |  ENDO 2000: AndroGel (Testosterone) Improves Sexual Function and Strength In Testosterone Deficient Men TORONTO, ON -- June 22, 2000 -- Data presented show that the new testosterone replacement therapy, testosterone gel, which is available commercially as AndroGel® (testosterone gel) 1% CIII, improves sexual function, mood, muscle strength, bone mineral density and body composition in testosterone deficient men. Data also showed that this testosterone gel in the doses selected for the study gave consistent levels of testosterone in the blood that were higher than the usually recommended dose of a testosterone patch. This data, representing a study conducted by 16 research centers in the United States, was presented at the current ENDO 2000, the annual meeting of the Endocrine Society. The 227-man study, comparing a new testosterone gel (AndroGel 5g to 10 g/day) to the testosterone patch Androderm® (5mg/day), was the largest ever performed on men with low testosterone. The three arms of the study produced blood testosterone levels in the low normal, mid-normal and high normal range with the testosterone patch, low dose and high dose testosterone gels respectively. The study found that skin irritation was reported in only 5.5 percent of men using AndroGel, compared with 66 percent of men using the patch. Data also indicated that the testosterone gel in the 10g/day group significantly increased bone mineral density in the hip and spine as compared with the lower dose of testosterone gel and the patch, which showed no increase in bone mineral density. "The improvements in sexual function, mood, lean body mass, bone density and muscle strength support the potential physical and psychological benefits of a testosterone gel," said Ronald S. Swerdloff, M.D., chief and professor of medicine, division of endocrinology, at the Harbor-UCLA Research and Education Institute in Torrance, Calif. "In addition, the decreased skin irritation seen in men using the testosterone gel demonstrates an advantage of the gel delivery method." Men using this testosterone gel reached maximum improvement in sexual function and mood within the first 30 days of treatment. In addition, percent fat was decreased in men using testosterone gel (5g/day:-0. 90+ 0.32 Kg, and 10g/day: -1.05+ 0.22 Kg) but was not significantly decreased in the testosterone patch group. Mean muscle strength was increased in the leg press exercise by 11 to 13 Kg and moderate mean muscle increases were also shown in arm/chest muscle strength. Lean body mass was increased in men taking 10g/day of testosterone gel by (2.74+ 0.28 Kg, p=0.0002) compared to those taking 5g/day. AndroGel is a clear, colorless topical gel that men apply once daily to the shoulders, upper arms and/or abdomen. Upon application, this testosterone gel dries within a few minutes. The skin absorbs the testosterone and serves as a reservoir for the hormone, which slowly enters the bloodstream. Normal testosterone levels are restored soon after application. The U.S. Food and Drug Administration (FDA) approved AndroGel in February 2000 for replacement therapy in men for conditions associated with low testosterone. Side effects experienced by patients in this study were anticipated and manageable. They included increases in hematocrit and hemoglobin without significant changes in lipids. Increases in average prostate specific androgen (PSA) levels remained in the normal range and correlated with testosterone levels. Men using the testosterone gel were able to adjust their dose up or down to 7.5g/day on day 90 if serum testosterone concentrations were outside the normal male range. No dose adjustment occurred in men taking the patch. Androgens are contraindicated in men with carcinoma of the breast, or known or suspected carcinoma of the prostate. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. AndroGel is not indicated for use in women and has not been evaluated in women. Pregnant women should avoid skin contact with AndroGel application sites in men. Testosterone may cause fetal harm. Studies have shown that during vigorous skin-to-skin contact some of the testosterone in the testosterone gel can be transferred to the untreated individual. Residual testosterone on the skin can be removed with soap and water. Testosterone should not be used to improve athletic performance. Related Link: AndroGel (testosterone gel) 1%.
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