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| |  Transdermal Testosterone Replacement Well Tolerated in Hypogonadal Men With Diabetes or Metabolic Syndrome: Presented at EAU By Jill Stein MILAN, Italy -- March 30, 2008 -- Early data demonstrate that transdermal testosterone replacement is well tolerated in hypogonadal men with type 2 diabetes or metabolic syndrome. These findings, announced March 28 at the 23rd Annual European Association of Urology (EAU) Congress, are based on early results in the ongoing Testosterone Replacement in Hypogonadal Men With Either Metabolic Syndrome or Type 2 Diabetes (TIMES2) study. The TIMES2 study is presently examining the effect of a metered-dose topical 2% testosterone gel on insulin resistance, glycaemic control, lipids, erectile function, quality of life, and other parameters in 221 hypogonadal male patients with type 2 diabetes or metabolic syndrome. All participants have been randomised to treatment with 3 g of 2% testosterone gel per day (60 mg testosterone) or placebo gel. At 14 days, all patients undergo peak serum testosterone measurement and dose titration. Over 75% of the patients enrolled in the TIMES2 trial have metabolic syndrome, about two thirds have type 2 diabetes, and nearly half have both medical conditions. Sixty-eight percent of patients completed treatment to 6 months. An analysis of 6-month safety data in the entire study population demonstrated an adverse-event rate of 57%. Adverse events were usually mild, and involved infections such as nasopharyngitis. Fourteen of the 221 patients developed serious adverse events, which were assessed by investigators to be unrelated to the study drug. The most commonly reported serious adverse events were gastrointestinal disorders, cardiac disorders, and neoplasms. The study medication was found to be well tolerated to date, noted Eric J.H. Meuleman, MD, PhD, Professor, Andrological Urology, Free University Medical Centre, Amsterdam, The Netherlands. The most common baseline symptoms in patients with both metabolic syndrome and type 2 diabetes were as follows: decreased erectile function (54%), decreased libido (45%), and fatigue (38%). "Our interim data indicate that there is a high incidence of symptoms such as fatigue, sexual dysfunction, and changes in body composition and mood among hypogonadal men with type 2 diabetes or metabolic syndrome -- and these rates are higher than expected for the general male population," Dr. Meuleman noted. Low testosterone levels are associated with an increased risk for development of type 2 diabetes and metabolic syndrome due to improved glucose metabolism. Evidence suggests that restoring testosterone levels may improve glycaemic control and insulin sensitivity, thereby improving the cardiovascular risk profile of these men, Dr. Meuleman added. Funding for this study was provided by ProStrakan Group plc, Galashiels, Scotland.
[Presentation title: A Double-Blind, Placebo-Controlled Study on the Effects of Transdermal Testosterone Replacement in Men With type 2 Diabetes or Metabolic Syndrome: the TIMES2 Study. Abstract 904]
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