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Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Avanafil
Sildenafil
Sponsored by
Eduardo Vargas-Baquero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Nacional de ParaplejicosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Avanafil

Sildenafil

Arm Description

Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).

Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil)

Outcomes

Primary Outcome Measures

IIEF-EF
Erectile Function Domain questionnaire of the International Index of Erectile Function.

Secondary Outcome Measures

SLQQ-Part II
Sexual life quality Questionnaire
GAQ
Global Impression of efficacy

Full Information

First Posted
April 21, 2017
Last Updated
May 26, 2017
Sponsor
Eduardo Vargas-Baquero
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1. Study Identification

Unique Protocol Identification Number
NCT03169582
Brief Title
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction
Official Title
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Vargas-Baquero

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
non- inferiority, randomized, crossover, open clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avanafil
Arm Type
Active Comparator
Arm Description
Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).
Arm Title
Sildenafil
Arm Type
Active Comparator
Arm Description
Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil)
Intervention Type
Drug
Intervention Name(s)
Avanafil
Other Intervention Name(s)
no other interventions
Intervention Description
Drug administration (Avanafil)
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
no other interventions
Intervention Description
Drug administration (Sildenafil)
Primary Outcome Measure Information:
Title
IIEF-EF
Description
Erectile Function Domain questionnaire of the International Index of Erectile Function.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
SLQQ-Part II
Description
Sexual life quality Questionnaire
Time Frame
2 years
Title
GAQ
Description
Global Impression of efficacy
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Vargas-Baquero, MD
Phone
+34925247700
Ext
47748
Email
edua33@hotmail.com
Facility Information:
Facility Name
Hospital Nacional de Paraplejicos
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Vargas-Baquero, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

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