Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction
- Registration Number
- NCT03169582
- Lead Sponsor
- Eduardo Vargas-Baquero
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 78
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sildenafil Sildenafil Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil) Avanafil Avanafil Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).
- Primary Outcome Measures
Name Time Method IIEF-EF 2 years Erectile Function Domain questionnaire of the International Index of Erectile Function.
- Secondary Outcome Measures
Name Time Method SLQQ-Part II 2 years Sexual life quality Questionnaire
GAQ 2 years Global Impression of efficacy
Trial Locations
- Locations (1)
Hospital Nacional de Paraplejicos
🇪🇸Toledo, Spain