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

Phase 4

Completed

• Conditions: Impotence; Spinal Cord Trauma; Injuries, Spinal Cord; Erectile Dysfunction; Spinal Cord Injury
• Interventions: Drug: placebo; Drug: sildenafil

• 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

Study Timeline

• Study Start: 2002-09
• Study Completion: 2003-08
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

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