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