Men With Low Testosterone Levels
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTestosterone Enanthate
Testosterone Enanthate
OTHERPlacebo
placebo
Sponsors
Solvay Pharmaceuticals
Watson Pharmaceuticals
Leonard S. Marks, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The screening evaluation consisted of: 1. medical history, which included the androgen deficiency of the aging male questionnaire 2. physical examination 3. multiphasic serum panel 4. measurement of total serum testosterone and PSA levels
Exclusion criteria
included: 1. use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis 2. serum PSA level greater than 10.0 ng/mL 3. refusal or inability to undergo prostate biopsies 4. presence of prostate cancer on initial biopsy results.
Countries
United States
Outcome results
None listed