Repros Therapeutics announced initiation of its Phase 2 study of Androxal (enclomiphene) for the treatment of type 2 diabetes in men with low testosterone. This trial is being conducted at nine sites across the US including both academic and private practices and will enroll up to 150 patients. In previous studies, in a subset of hypogonadal men with elevated glucose, Androxal showed a statistically and clinically significant reduction in morning fasting glucose levels while elevating testosterone. With roughly 20 subjects per arm, Androxal doses of either 12.5mg or 25mg achieved a median reduction >10mg/dL of glucose in men with elevated fasting glucose levels. The change from baseline was statistically significant for both groups, p<0.02.

Androxal is an orally active small molecule under development that restores normal pituitary response in men resulting in normalization of testosterone and luteinizing hormone (LH) levels.

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