A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
Phase 4
Completed
- Conditions
- ImpotenceSpinal Cord TraumaInjuries, Spinal CordErectile DysfunctionSpinal Cord Injury
- Interventions
- Drug: placebo
- Registration Number
- NCT00654082
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 88
Inclusion Criteria
-Patients were men with spinal cord injury and erectile dysfunction
Exclusion Criteria
-N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 2 placebo - Arm 1 sildenafil -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 the International Index of Erectile Function (IIEF) Weeks 0, 6, 8, and 14 Intercourse success rate derived from patient event log Weeks 0, 6, 8, and 14 Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions Weeks 0, 6, 8, and 14
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇹🇷Konya, Turkey