EFFICACY OF TESTOSTERONE GEL FOR HORMONAL REPLACEMENT IN HYPOGONADAL MEN

$0M01FY2000RRNIH

Johns Hopkins University, Baltimore MD

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Abstract

Results from phase I testing of DHT-gel, which was a pharmacokinetic study to compare 3 doses of 16, 32 and 64 mg/day provide adequate androgen levels to men aged 60-80 years. Before treatment , mean serum DHT and T levels over 24 hours ranged between 50 to 70 ng/dL (normal range) and 350 to 470 ng/dL (normal range) respectively, and were not different among the three dose groups. At day 14, the mean serum DHT 24 hours after application of gel were 268 +< 44, 370 +, 35 and 616 +< 108 ng/dL in the 16, 32 and 64 mg/day DHT groups respectively. No evidence of skin irritation was found in patients with DHT-gel in the phase I study. We are now in the phase II aspect of this study and continue to recruit subjects.

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