Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

The screening evaluation consisted of:

• medical history, which included the androgen deficiency of the aging male questionnaire
• physical examination
• multiphasic serum panel
• measurement of total serum testosterone and PSA levels

Exclusion criteria

included:

• use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
• serum PSA level greater than 10.0 ng/mL
• refusal or inability to undergo prostate biopsies
• presence of prostate cancer on initial biopsy results.