Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial

The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal cord injury erectile dysfunction. The study has the characteristics of a non- inferiority, randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile Function Domain questionnaire of the International Index of Erectile Function IIEF).

This is an interventional study

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Avanafil; Drug: Sildenafil

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45071
    • Recruiting
    • Hospital Nacional de Parapléjicos
    • Contact: Eduardo Vargas-Baquero, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Spinal cord injury
• Erectile dysfunction
• No Medical Contraindication to use Avanafil and/or Sildenafil
• Able to provide informed consent
• Able to complete questionnaires

Exclusion Criteria:

• Medical Contraindication to use Avanafil and/or Sildenafil
• No spinal cord injury
• Congenital spinal cord injury
• Not able to provide informed consent
• Not able to complete questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Avanafil; Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).	Drug: Avanafil; Drug administration (Avanafil); Other Names: no other interventions
Active Comparator: Sildenafil; Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil)	Drug: Sildenafil; Drug administration (Sildenafil); Other Names: no other interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF-EF	Erectile Function Domain questionnaire of the International Index of Erectile Function.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLQQ-Part II	Sexual life quality Questionnaire	2 years
GAQ	Global Impression of efficacy	2 years

Collaborators and Investigators

• Sponsor: Eduardo Vargas-Baquero

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Spinal Cord Injuries; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: HNParaplejicos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No