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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
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