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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00654082
First received: March 31, 2008
Last updated: April 2, 2008
Last verified: April 2008
  Purpose

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
Impotence
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

  Eligibility

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

Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

-N/A

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Turkey
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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
Retinitis Pigmentosa
Erectile Dysfunction
Spinal Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Back Injuries
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014