Official Title: “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.

Study Type: Interventional

Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Study Primary Completion Date: November 2012

Intervention(s) in this Clinical Trial

• Drug: Testim® + Viagra®
  • Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily and Viagra® 25 mg tablet daily at night
• Drug: Placebo Testim® + Viagra®
  • Placebo Testim® 5 g of gel (one tube) containing 50 mg of testosterone once daily and Viagra® 25mg every night Viagra® = 25 mg tablet daily at night

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
• Placebo Comparator: 2
  • Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night

Primary Measures

• The primary outcome of the study is to evaluate efficacy of testosterone replacement therapy (TRT) in men following radical prostatectomy in improving erectile function using the change in SHIM score at 6 months after initial screening visit.
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• The secondary outcome measure includes the change in the IIEF, ADAM and EPIC scores 6 months after the initial screening visit.
  • Time Frame: 6 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Baylor College of Medicine

Overall Clinical Trial Officials and Contacts

Mohit Khera, MD Principal Investigator Baylor College of Medicine  

Overall Contact: Sharon Harrison 713-798-2240 sharons@bcm.edu

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00848497

Study ID Number: H-21148

ClinicalTrials.gov Identifier: NCT00848497

Health Authority: United States: Food and Drug Administration