Back to resultsA Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
Primary Purpose
Spinal Cord Injury, Erectile Dysfunction, Spinal Cord Trauma
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
sildenafil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
-Patients were men with spinal cord injury and erectile dysfunction
Exclusion Criteria:
-N/A
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections
Secondary Outcome Measures
Responses to the International Index of Erectile Function (IIEF)
Responses to the Global Efficacy Assessment (GEA) Question
Responses to questions on the Quality of Life (QoL) Questionnaire
Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions
Intercourse success rate derived from patient event log
Full Information
NCT ID
NCT00654082
First Posted
March 31, 2008
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00654082
Brief Title
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Erectile Dysfunction, Spinal Cord Trauma, Injuries, Spinal Cord, Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Responses to the International Index of Erectile Function (IIEF)
Time Frame
Weeks 0, 6, 8, and 14
Title
Responses to the Global Efficacy Assessment (GEA) Question
Time Frame
Weeks 0, 6, 8, and 14
Title
Responses to questions on the Quality of Life (QoL) Questionnaire
Time Frame
Weeks 0, 6, 8, and 14
Title
Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions
Time Frame
Weeks 0, 6, 8, and 14
Title
Intercourse success rate derived from patient event log
Time Frame
Weeks 0, 6, 8, and 14
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Patients were men with spinal cord injury and erectile dysfunction
Exclusion Criteria:
-N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bahcelievler
State/Province
Istanbul
ZIP/Postal Code
34580
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Balcova
State/Province
Izmir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Ankara
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Bursa
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Konya
Country
Turkey
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481103&StudyName=A%20Study%20Evaluating%20the%20Efficacy%20and%20Safety%20of%20Sildenafil%20in%20Men%20with%20Traumatic%20Spinal%20Cord%20Injury%20and%20Erectile%20Dysfunction.
Description
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Learn more about this trial
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
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