Novel Testosterone Gel Significantly Improves Insulin Sensitivity and Sexual Function in Hypogonadal Men With Type 2 Diabetes and Metaboli...( New Data Highlights the Need for...),Health

New Data Highlights the Need for Testosterone Screening in At-Risk

Hypogonadal Men

BEDMINSTER, N.J., June 17 /PRNewswire/ -- New data from a 12-month, international, multi-center study showed that treatment for low testosterone with Tostran(R), a topical, metered dose 2% testosterone gel, significantly improves insulin sensitivity and sexual function among hypogonadal men with Type 2 diabetes and/or Metabolic Syndrome. These data were presented today at the Endocrine Society's 90th Annual Meeting in San Francisco. Tostran, also marketed as Fortigel, Tostrex and Itnogen, is available in 13 countries across Europe, and ProStrakan (LSE: PSK), an international specialty pharmaceutical company, plans to file Tostran with U.S. regulatory authorities later this year.

The Testosterone replacement In hypogonadal men with either MEtabolic Syndrome or type 2 diabetes (TIMES 2) study looked at the effects of Tostran on insulin resistance, diabetic control, lipids, quality of life and symptoms of hypogonadism. The placebo-controlled study of 220 hypogonadal men met its primary endpoint by showing a statistically significant improvement in insulin sensitivity in testosterone treated patients at six and 12 months (p=0.05 and p=0.01, respectively), as measured by homeostasis model assessment as an index of insulin resistance (HOMA-IR). Further, measured by the Index of Erectile Function (IIEF), patients using the testosterone gel saw significant improvement in sexual function at six and 12 months (p <0.05).

"These data tell us that replacement therapy for low testosterone in hypogonadal males not only improves sexual function but, more importantly, can also have impact on insulin sensitivity," said lead investigator T. Hugh Jones BSc, MD, FRCP, Consultant Physician & Endocrinologist and Hon. Professor of Andrology, Barnsley Hospital and University of Sheffield, UK. "The TIMES 2 study indicates for the first time the role
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