Testosterone for Penile Rehab After Radical Prostatectomy
| Status: | Completed |
|---|---|
| Conditions: | Erectile Dysfunction |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | November 2007 |
| End Date: | November 2013 |
| Contact: | Sharon Harrison |
| Email: | sharons@bcm.edu |
| Phone: | 713-798-2240 |
Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
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 randomized (like flipping a coin) to one of two groups. One
group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and
the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.
Subjects will begin drug treatment 3 months after the initial screening visit and will take
study drug for 3 months only. Participation will end at the end of the 6-month visit.
therapy (TRT) in men following surgery to remove the prostate in improving erectile
function. Subjects will be randomized (like flipping a coin) to one of two groups. One
group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and
the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.
Subjects will begin drug treatment 3 months after the initial screening visit and will take
study drug for 3 months only. Participation will end at the end of the 6-month visit.
Inclusion Criteria:
- Males, 18 years of age or older, with low testosterone levels.
- Must have undergone a bilateral nerve sparing radical prostatectomy.
- Nadir PSA 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 Criteria:
- 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.
We found this trial at
1
site
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
