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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3
Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily. This was the dose given to the patient which he started.
Placebo Testim® 5 g of gel (one tube)
Viagra 25mg was the dose given to the patient which he started.
Baylor College of Medicine
Houston, Texas, United States
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED
Time frame: Baseline and 6 months
Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.
There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function
Time frame: Baseline and 6 months
Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
ADAM scores of one evaluated patient. ADAM is 10 questions ("yes" or "no" answers) and if you answer yes to question 1 or 7 or "yes" to any 3 questions you are said to test "positive" to the ADAM questionnaire.
Time frame: Baseline and 6 months
Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better
Time frame: Basline and 6 months
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