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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654082

Enrollment

Registered

2008-04-07

Start date

2002-09-30

Completion date

2003-08-31

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Impotence, Injuries, Spinal Cord, Spinal Cord Injury, Spinal Cord Trauma

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.

Interventions

DRUGsildenafil

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion criteria

-N/A

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026