NCT01315262

On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy

On Demand Versus Daily Sildenafil for Patients Undergoing Bilateral Nerve Sparing Radical Prostatectomy: a Randomized, Open Label, Parallel Group Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment of erectile dysfunction (ED). Objectives: * To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following radical prostatectomy. * To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily after radical prostatectomy.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Sildenafil	1:1 Viagra 100 mg daily (taken either at bedtime - if sexual intercourse is not expected - or 1 hour prior to sexual intercourse, no more than one 100 mg dose of sildenafil per day) vs. Viagra 100mg OD (i.e. one hour prior to sexual intercourse)

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2011-03-15
• Last updated: 2011-03-29

Locations

1 site across 1 country: Italy