MedTrace Logo

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

NCT00654082 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-02-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Completion
2003-08-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00654082 on ClinicalTrials.gov