Testosterone for Penile Rehabilitation After Radical Prostatectomy
Stopped early · Early Phase 1 · Has a placebo group
Conditions studied: Hypogonadism, Erectile Dysfunction
In brief
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.
Key facts
- Study ID
- NCT00848497
- Run by
- Mohit Khera
- People needed
- 3
- Starts
- 2007-11-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2015-06-19
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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