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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00654082

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

17.6

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury Erectile Dysfunction Spinal Cord Trauma Injuries, Spinal Cord Impotence	Drug: sildenafil Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2002

Actual Study Completion Date :

Aug 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: sildenafil 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 Comparator: Arm 2	Drug: placebo placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: sildenafil

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 Comparator: Arm 2

Drug: placebo

placebo tablet by mouth 1 hour prior to anticipated sexual activity, but not more than once daily (QD) for 6 weeks

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

-N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bahcelievler	Istanbul	Turkey	34580
2	Pfizer Investigational Site	Balcova	Izmir	Turkey
3	Pfizer Investigational Site	Ankara		Turkey
4	Pfizer Investigational Site	Bursa		Turkey
5	Pfizer Investigational Site	Konya		Turkey