NCT00848497

Testosterone for Penile Rehabilitation After Radical Prostatectomy

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mohit Khera · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Testim®	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.
OTHER	Placebo Testim®	Placebo Testim® 5 g of gel (one tube)
DRUG	Viagra®	Viagra 25mg was the dose given to the patient which he started.

Timeline

• Start date: 2007-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-02-20
• Last updated: 2015-06-19
• Results posted: 2015-06-19

Locations

1 site across 1 country: United States