A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
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
1 other identifier
interventional
88
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2002
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedFebruary 1, 2021
January 1, 2021
March 31, 2008
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of subjects who indicated a preference for either treatment and who said that the treatment improved their erections
Weeks 6 and 14
Secondary Outcomes (5)
Responses to the International Index of Erectile Function (IIEF)
Weeks 0, 6, 8, and 14
Responses to the Global Efficacy Assessment (GEA) Question
Weeks 0, 6, 8, and 14
Responses to questions on the Quality of Life (QoL) Questionnaire
Weeks 0, 6, 8, and 14
Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions
Weeks 0, 6, 8, and 14
Intercourse success rate derived from patient event log
Weeks 0, 6, 8, and 14
Study Arms (2)
Arm 1
ACTIVE COMPARATORArm 2
PLACEBO COMPARATORInterventions
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 tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks
Eligibility Criteria
You may qualify if:
- Patients were men with spinal cord injury and erectile dysfunction
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Pfizer Investigational Site
Bahçelievler, Istanbul, 34580, Turkey (Türkiye)
Pfizer Investigational Site
Balçova, İzmir, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, Turkey (Türkiye)
Pfizer Investigational Site
Bursa, Turkey (Türkiye)
Pfizer Investigational Site
Konya, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 7, 2008
Study Start
September 1, 2002
Study Completion
August 1, 2003
Last Updated
February 1, 2021
Record last verified: 2021-01