Clinical Trials Logo
  1. Home
  2. Erectile Dysfunction
  3. NCT03169582
  4. Details
NCT03169582 Clinical Trial

Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03169582
Other study ID # HNParaplejicos
Secondary ID
Status Recruiting
Phase Phase 4
First received April 21, 2017
Last updated May 26, 2017
Start date April 1, 2016
Est. completion date June 1, 2018

Study information
Verified date May 2017
Source Hospital Nacional de Parapléjicos de Toledo
Contact Eduardo Vargas-Baquero, MD
Phone +34925247700
Email edua33@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 78
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Avanafil
Drug administration (Avanafil)
• Sildenafil
Drug administration (Sildenafil)

Locations
Country Name City State
Spain Hospital Nacional de Paraplejicos Toledo

Sponsors (1)
Lead Sponsor Collaborator
Eduardo Vargas-Baquero

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary IIEF-EF Erectile Function Domain questionnaire of the International Index of Erectile Function. 2 years
Secondary SLQQ-Part II Sexual life quality Questionnaire 2 years
Secondary GAQ Global Impression of efficacy 2 years
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4