NCT00654082

A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

A Placebo-Controlled, Randomized, Two-Way Cross-Over, Double-Blind, Flexible Dose, Multicenter Study to Evaluate the Efficacy and Safety of Viagra in Male Patients With Traumatic Spinal Cord Injury and Erectile Dysfunction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.

Conditions

• Spinal Cord Injury
• Erectile Dysfunction
• Spinal Cord Trauma
• Injuries, Spinal Cord
• Impotence

Interventions

Type	Name	Description
DRUG	sildenafil	sildenafil 50 mg tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks; after 2 weeks on treatment, doses could be escalated to 100 mg or reduced to 25 mg
DRUG	placebo	placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks

Timeline

• Start date: 2002-09-01
• Completion: 2003-08-01
• First posted: 2008-04-07
• Last updated: 2021-02-01

Locations

5 sites across 1 country: Turkey (Türkiye)