ProStrakan has announced positive data from a 12-month, international, multi-center study, which showed that treatment for low testosterone with Tostran, a topical, metered dose 2% testosterone gel, significantly improves insulin sensitivity and sexual function among hypogonadal men with Type 2 diabetes or metabolic syndrome.
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The Testosterone replacement in hypogonadal men with either metabolic syndrome or Type 2 diabetes 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.
Further, measured by the index of erectile function, patients using the testosterone gel saw significant improvement in sexual function at six and 12 months (p <0.05). Hugh Jones, lead investigator of the study, said: "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."
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