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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 31, 2008
Last updated: April 2, 2008
Last verified: April 2008
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.

Condition Intervention Phase
Spinal Cord Injury
Erectile Dysfunction
Spinal Cord Trauma
Injuries, Spinal Cord
Drug: sildenafil
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections [ Time Frame: Weeks 6 and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responses to the International Index of Erectile Function (IIEF) [ Time Frame: Weeks 0, 6, 8, and 14 ] [ Designated as safety issue: No ]
  • Responses to the Global Efficacy Assessment (GEA) Question [ Time Frame: Weeks 0, 6, 8, and 14 ] [ Designated as safety issue: No ]
  • Responses to questions on the Quality of Life (QoL) Questionnaire [ Time Frame: Weeks 0, 6, 8, and 14 ] [ Designated as safety issue: No ]
  • Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions [ Time Frame: Weeks 0, 6, 8, and 14 ] [ Designated as safety issue: No ]
  • Intercourse success rate derived from patient event log [ Time Frame: Weeks 0, 6, 8, and 14 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: September 2002
Study Completion Date: August 2003
Arms Assigned Interventions
Active Comparator: Arm 1 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 Comparator: Arm 2 Drug: placebo
placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00654082

Pfizer Investigational Site
Bahcelievler, Istanbul, Turkey, 34580
Pfizer Investigational Site
Balcova, Izmir, Turkey
Pfizer Investigational Site
Ankara, Turkey
Pfizer Investigational Site
Bursa, Turkey
Pfizer Investigational Site
Konya, Turkey
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00654082     History of Changes
Other Study ID Numbers: A1481103 
Study First Received: March 31, 2008
Last Updated: April 2, 2008
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Spinal Cord Injuries
Erectile Dysfunction
Spinal Injuries
Back Injuries
Central Nervous System Diseases
Genital Diseases, Male
Mental Disorders
Nervous System Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Sildenafil Citrate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2016