Testosterone for Penile Rehabilitation After Radical Prostatectomy

Early Phase 1

Terminated

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 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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 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.

Arm && Interventions

Group	Intervention	Description
Testim® + Viagra®	Testim®	Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Testim® + Viagra®	Viagra®	Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
Placebo Testim® + Viagra®	Viagra®	Placebo Testim® gel once daily + Viagra® 25 mg tablet every night
Placebo Testim® + Viagra®	Placebo Testim®	Placebo Testim® gel once daily + Viagra® 25 mg tablet every night

Primary Outcome Measures

Name	Time	Method
Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.	Baseline and 6 months	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

Secondary Outcome Measures

Name	Time	Method
Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.	Baseline and 6 months	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.
Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.	Baseline and 6 months	There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function
Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.	Basline and 6 months	EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better