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Trial record 15 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Erectile Dysfunction"

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03169582
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Vargas-Baquero, Hospital Nacional de Parapléjicos de Toledo

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


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Avanafil Drug: Sildenafil Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: non- inferiority, randomized, crossover, open clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Avanafil
Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).
Drug: Avanafil
Drug administration (Avanafil)
Other Name: no other interventions
Active Comparator: Sildenafil
Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil)
Drug: Sildenafil
Drug administration (Sildenafil)
Other Name: no other interventions



Primary Outcome Measures :
  1. IIEF-EF [ Time Frame: 2 years ]
    Erectile Function Domain questionnaire of the International Index of Erectile Function.


Secondary Outcome Measures :
  1. SLQQ-Part II [ Time Frame: 2 years ]
    Sexual life quality Questionnaire

  2. GAQ [ Time Frame: 2 years ]
    Global Impression of efficacy



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169582


Contacts
Contact: Eduardo Vargas-Baquero, MD +34925247700 ext 47748 edua33@hotmail.com

Locations
Spain
Hospital Nacional de Paraplejicos Recruiting
Toledo, Spain, 45071
Contact: Eduardo Vargas-Baquero, MD         
Sponsors and Collaborators
Eduardo Vargas-Baquero

Responsible Party: Eduardo Vargas-Baquero, Principal Investigator, Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier: NCT03169582     History of Changes
Other Study ID Numbers: HNParaplejicos
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Erectile Dysfunction
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents