In this randomized study, we were investigating the efficacy and safety of a new testosterone medication in the form of a topical gel. the investigators wanted to show that the testosterone-gel (T-gel) would be as efficacious and safe as the current FDA approved Androderm patches. Hypogonadal men (defined as total testosterone of 300 ng/dl or less) who were 60 years or younger were randomized to one of three arms: 1) Androderm patch, 2) 50 mg of T-gel, or 3) 100 mg of T-gel. Twenty-two hypogonadal men were enrolled into the study. Two men dropped out of the study at mid-point (Day 90). One dropped out due to adverse events of the Androderm. He was experiencing erythema and edema of the patches. The other man was dropped at the request of the sponsoring company because he was not complying with the protocol. The other twenty men completed without any problems. The data is still being analyzed, but some preliminary data is available. It appears that the T-gel sustained the men's testosterone level better than the Androderm patches after 90 days. Erythema and edema are practically nonexistatnt with the T-gel while the Androderm group had a high occurrence of these symptoms. Using the DEXA scan, it was found that the supplement of testosterone lowers adipose tissue and increases lean body mass.
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