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Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03169582
Enrollment
78
Registered
2017-05-30
Start date
2016-04-01
Completion date
2018-06-01
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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

Interventions

Drug administration (Avanafil)

DRUGSildenafil

Drug administration (Sildenafil)

Sponsors

Eduardo Vargas-Baquero
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

non- inferiority, randomized, crossover, open clinical trial

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IIEF-EF2 yearsErectile Function Domain questionnaire of the International Index of Erectile Function.

Secondary

MeasureTime frameDescription
SLQQ-Part II2 yearsSexual life quality Questionnaire
GAQ2 yearsGlobal Impression of efficacy

Countries

Spain

Contacts

Primary ContactEduardo Vargas-Baquero, MD
edua33@hotmail.com+34925247700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026