Status:
COMPLETED
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Lead Sponsor:
Leonard S. Marks, M.D.
Collaborating Sponsors:
Solvay Pharmaceuticals
Watson Pharmaceuticals
Conditions:
Men With Low Testosterone Levels
Eligibility:
MALE
50+ years
Phase:
PHASE2
PHASE3
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 objective...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00161304
Start Date
April 1 2003
End Date
November 1 2004
Last Update
April 28 2021
Active Locations (1)
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1
Urological Sciences Research Foundation
Culver City, California, United States, 90232