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

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ClinicalTrials.gov Identifier: NCT00654082
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Erectile Dysfunction Spinal Cord Trauma Injuries, Spinal Cord Impotence Drug: sildenafil Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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
Study Start Date : September 2002
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Responses to the International Index of Erectile Function (IIEF) [ Time Frame: Weeks 0, 6, 8, and 14 ]
  2. Responses to the Global Efficacy Assessment (GEA) Question [ Time Frame: Weeks 0, 6, 8, and 14 ]
  3. Responses to questions on the Quality of Life (QoL) Questionnaire [ Time Frame: Weeks 0, 6, 8, and 14 ]
  4. Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions [ Time Frame: Weeks 0, 6, 8, and 14 ]
  5. Intercourse success rate derived from patient event log [ Time Frame: Weeks 0, 6, 8, and 14 ]


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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:


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00654082     History of Changes
Other Study ID Numbers: A1481103
First Posted: April 7, 2008    Key Record Dates
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