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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00654082

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Erectile Dysfunction Injuries Spinal Cord Injuries Wounds

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

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
Arm 1: Active Comparator	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
Arm 2: Placebo Comparator	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

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

Locations

Turkey
Pfizer Investigational Site
ANKARA, Turkey
Pfizer Investigational Site
BURSA, Turkey
Pfizer Investigational Site
KONYA, Turkey
Turkey, ISTANBUL
Pfizer Investigational Site
BAHCELIEVLER, ISTANBUL, Turkey, 34580
Turkey, IZMIR
Pfizer Investigational Site
BALCOVA, IZMIR, Turkey

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Sildenafil
Cardiovascular Agents
Trauma, Nervous System

Genital Diseases, Male
Spinal Cord Injuries
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Spinal Injuries
Mental Disorders
Back Injuries
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Trauma, Nervous System

Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Spinal Cord Injuries
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Mental Disorders
Spinal Injuries
Therapeutic Uses
Back Injuries
Erectile Dysfunction

ClinicalTrials.gov processed this record on September 09, 2009