Status:
COMPLETED
The Effects of Testosterone on Prostate Tissue (ACYP-1)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hypogonadism
Contraception
Eligibility:
MALE
35-55 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may im...
Detailed Description
We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an experimental drug. We want to see their effects on levels of hormones in the blood and prostate. In addition, w...
Eligibility Criteria
Inclusion
- Males between 35 and 55, normal serum testosterone levels, normal gonadal function
Exclusion
- History of prostate cancer, PSA\>2.0, AUA BPH symptom score \>10, History of testosterone or anabolic steroid use, chronic medical illness or prostate disease, active serious infection or immunosuppression, history of a bleeding disorder or need for anticoagulation, abnormal digital rectal exam, abnormal prostate ultrasound, first degree relative with history of prostate cancer
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00161486
Start Date
July 1 2004
End Date
November 1 2004
Last Update
September 19 2008
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195