Previous studies using exogenous testosterone have not shown any clinically relevant impact on measures of glycemic control in type 2 diabetics. A study conducted by Solvay (now Abbott) showed no positive effect on glycemic control in men with diabetes. (Link: global.abbottgrowth/static/wma/pdf/1/3/4/4/2/S176.2.101.pdf). These findings are consistent with those observed for men on AndroGel?® in the retrospective analysis from the 200 patient study completed by Repros. Unlike AndroGel, Androxal exhibited clinically significant reductions in fasting plasma glucose in the same population. These reductions were similar to those reported by Glaxo for the 4 mg dose of Avandia?®. Unlike Avandia, Androxal has exhibited no cardiovascular side effects to date.

Dr. Ronald Wiehle, Repros' VP of Research, noted, "Very recently the FDA has required companies that market GnRH agonists to add a warning to their label indicating the potential for the induction of diabetes. These drugs work centrally to suppress testicular synthesis of testosterone. We believe that action by the agency, the Solvay study and the prior work of Pitteloud et al. (JCEM 90:2636, 2005), who concluded that insulin resistance was associated with a decrease in testicular testosterone, all strengthen our hypothesis that Androxal can improve glycemic control." He further remarked, "Androxal does not work like either GnRH agonists or topical gels but does restore testicular function and appears to modify metabolic processes that have a positive impact on glycemic control."

Repros has an issued patent teaching the use of Androxal in restoration of testicular function and has pending patent applications that deal specifically with the drug's ability to impact glycemic control.

SOURCE Repros Therapeutics Inc.