On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy

NCT01315262 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-03-29

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01315262 on ClinicalTrials.gov