Status:
TERMINATED
Testosterone for Penile Rehabilitation After Radical Prostatectomy
Lead Sponsor:
Mohit Khera
Conditions:
Hypogonadism
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be r...
Detailed Description
There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.
Eligibility Criteria
Inclusion
- Males, 18 years of age or older, with low testosterone levels.
- Must have undergone a bilateral nerve sparing radical prostatectomy.
- Nadir PSA (Prostate-Specific Antigen) values should be less than 0.01 ng/ml on two consecutive occasions separated by 4 weeks at the start of treatment.
- Must give informed consent.
- Must be willing to complete follow-up visits.
Exclusion
- Testosterone level greater than 300 ng/ dl
- Hemoglobin level greater than 18 ng/dl.
- Positive surgical margins or evidence of residual prostate cancer after surgery.
- Clinically suspected advanced disease or actual evidence of metastatic prostate cancer.
- Primary Gleason Grade greater than 3 or secondary Gleason Grade greater than 4 in the final pathologic specimen will be excluded.
- Taking nitrates or with contraindications to the use of Viagra or androgen therapy will be excluded.
- Known hypersensitivity to any component of the tablet will be excluded.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00848497
Start Date
November 1 2007
End Date
March 1 2013
Last Update
June 19 2015
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030