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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:
ClinicalTrials.gov Identifier:
NCT00654082
First Posted: April 7, 2008
Last Update Posted: April 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Responses to the International Index of Erectile Function (IIEF) [ Time Frame: Weeks 0, 6, 8, and 14 ]
  • Responses to the Global Efficacy Assessment (GEA) Question [ Time Frame: Weeks 0, 6, 8, and 14 ]
  • Responses to questions on the Quality of Life (QoL) Questionnaire [ Time Frame: Weeks 0, 6, 8, and 14 ]
  • Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions [ Time Frame: Weeks 0, 6, 8, and 14 ]
  • Intercourse success rate derived from patient event log [ Time Frame: Weeks 0, 6, 8, and 14 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00654082     History of Changes
Other Study ID Numbers: A1481103
First Submitted: March 31, 2008
First Posted: April 7, 2008
Last Update Posted: April 7, 2008
Last Verified: April 2008

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


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