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

Viatris

Status and phase: Completed; Phase 4

Conditions: Impotence; Spinal Cord Trauma; Erectile Dysfunction; Spinal Cord Injury; Injuries, Spinal Cord

Treatments: Drug: placebo; Drug: sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654082

A1481103

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion criteria

-N/A

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: sildenafil

Arm 2

Placebo Comparator group

Treatment:

Drug: placebo