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Sponsors and Collaborators: |
Urological Sciences Research Foundation Solvay Pharmaceuticals Watson Pharmaceuticals |
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Information provided by: | Urological Sciences Research Foundation |
ClinicalTrials.gov Identifier: | NCT00161304 |
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.
Condition | Intervention | Phase |
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Men With Low Testosterone Levels |
Drug: Testosterone Enanthate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:Inclusion Criteria
Exclusion Criteria
United States, California | |
Urological Sciences Research Foundation | |
Culver City, California, United States, 90232 |
Principal Investigator: | Leonard S Marks, M.D. | Urological Sciences Research Foundation |
Study ID Numbers: | T-001 |
Study First Received: | September 8, 2005 |
Last Updated: | September 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00161304 |
Health Authority: | United States: Institutional Review Board |
Testosterone Methyltestosterone Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |