Spinal Cord Injury Clinical Trial
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
NCT number | NCT00654082 |
Other study ID # | A1481103 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2002 |
Est. completion date | August 2003 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: -Patients were men with spinal cord injury and erectile dysfunction Exclusion Criteria: -N/A |
Country | Name | City | State |
---|---|---|---|
Turkey | Pfizer Investigational Site | Ankara | |
Turkey | Pfizer Investigational Site | Bahcelievler | Istanbul |
Turkey | Pfizer Investigational Site | Balcova | Izmir |
Turkey | Pfizer Investigational Site | Bursa | |
Turkey | Pfizer Investigational Site | Konya |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Responses to the International Index of Erectile Function (IIEF) | Weeks 0, 6, 8, and 14 | ||
Secondary | Responses to the Global Efficacy Assessment (GEA) Question | Weeks 0, 6, 8, and 14 | ||
Secondary | Responses to questions on the Quality of Life (QoL) Questionnaire | Weeks 0, 6, 8, and 14 | ||
Secondary | Responses to Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questions | Weeks 0, 6, 8, and 14 | ||
Secondary | Intercourse success rate derived from patient event log | Weeks 0, 6, 8, and 14 |
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