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NCT00654082 Clinical Trial

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

Spinal Cord Injury Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00654082
Other study ID # A1481103
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2002
Est. completion date August 2003

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility Inclusion Criteria: -Patients were men with spinal cord injury and erectile dysfunction Exclusion Criteria: -N/A

Study Design

Related Conditions & MeSH terms

Intervention

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
• placebo
placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks

Locations
Country Name City State
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Bahcelievler Istanbul
Turkey Pfizer Investigational Site Balcova Izmir
Turkey Pfizer Investigational Site Bursa
Turkey Pfizer Investigational Site Konya

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections Weeks 6 and 14
Secondary Responses to the International Index of Erectile Function (IIEF) Weeks 0, 6, 8, and 14
Secondary Responses to the Global Efficacy Assessment (GEA) Question Weeks 0, 6, 8, and 14
Secondary Responses to questions on the Quality of Life (QoL) Questionnaire Weeks 0, 6, 8, and 14
Secondary Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions Weeks 0, 6, 8, and 14
Secondary Intercourse success rate derived from patient event log Weeks 0, 6, 8, and 14
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