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.
Inclusion Criteria: Inclusion Criteria
1. Male aged 50-80 years of age, ambulatory, and in good general physical and mental
health.
2. Clinical diagnosis of hypogonadism defined as a serum testosterone level less than 300
ng/dl on a morning serum sample during the screening period.
3. Answering yes to question 1 or 7 or to any three questions total on the Morley index
at baseline.
4. PSA <10 ng/ml
5. Subject is able to give informed consent.
Exclusion Criteria
1. Failure to meet the criteria for inclusion
2. History of allergy to testosterone or any components of the delivery system.
3. Significant abnormalities on pre-study clinical examination or laboratory
measurements.
4. Treatment with any investigational drug during the previous month.
5. Drug or alcohol abuse or dependence.
6. Concurrent use of testosterone and or any hormonal therapy, including health food
supplements and herbal products, that could alter serum testosterone levels or affect
the prostate (e. g. gonadotropic releasing hormone agonists, testosterone antagonists,
anabolic steroids, DHEA, androstenedione, PC-SPES, chrysin and tribulus terrestris,).
Use of alpha-reductase inhibitors or prostate phytotherapy within the past 3 months.
7. Use of antidepressant medications, oral glucocorticoids, or opioids.
8. PSA > 10 ng/ml and/or prostate biopsy positive for cancer at screening. Any patient
in whom there is a suspicion of prostate cancer must undergo appropriate testing to
rule out cancer prior to entry into the study.
9. IPSS score 20.
10. History of malignancy of any type (except basal cell carcinoma).
11. Patients with uncontrolled diabetes.
12. Patients with known or suspected bleeding disorder. Concurrent use of Coumadin and
other anticoagulants at the time of biopsy or if discontinuation of such therapy prior
to biopsy poses a risk to the patient.
13. Inability of the patient to provide written informed consent for any reason, including
legal incompetence, language or comprehension difficulty, and psychological,
psychiatric or emotional factors.
14. Inability of the patient to have transrectal ultrasonography with biopsy (for any
reason).
15. A history of any illness or condition that, in the opinion of the investigator, might
confound the results of the study or pose additional risk to the patient.
