Testosterone for Penile Rehabilitation After Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)

Conditions
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Hypogonadism, Erectile Dysfunction

Intervention / Treatment
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* Drug: Testim®
* Other: Placebo Testim®
* Drug: Viagra®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testim® + Viagra®<br>Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night | Drug: Testim®<br>* 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.<br>* Other names: Testim® is the brand name for testosterone gel.;Drug: Viagra®<br>* Viagra 25mg was the dose given to the patient which he started.<br>* Other names: Viagra® 25 mg tablet daily at night;|
| Placebo Comparator: Placebo Testim® + Viagra®<br>Placebo Testim® gel once daily + Viagra® 25 mg tablet every night | Other: Placebo Testim®<br>* Placebo Testim® 5 g of gel (one tube)<br>* Other names: Placebo Testim;Drug: Viagra®<br>* Viagra 25mg was the dose given to the patient which he started.<br>* Other names: Viagra® 25 mg tablet daily at night;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | Basline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hormone replacement therapy, radical prostatectomy, erectile dysfunctions, scheduled for removal of prostate gland