On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy
NCT01315262 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2011-03-29
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
Interventions
- 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)
Sponsors & Collaborators
-
Università Vita-Salute San Raffaele
lead OTHER
Principal Investigators
-
francesco montorsi, MD · Vita-Salute San Raffaele Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-09-30
- Completion
- 2012-12-31
Countries
- Italy
Study Locations
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