Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

NCT03169582 — Phase 4, Unknown, 78 participants, Eduardo Vargas-Baquero

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

Registry	NCT03169582
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	78 (Estimated)
Sponsor	Eduardo Vargas-Baquero (Other)
Conditions	Erectile Dysfunction
Interventions	Avanafil, Sildenafil (Drug)
Dates	start 2016-04-01, primary completion 2018-06-01 (estimated), completion 2018-06-01 (estimated), first posted 2017-05-30, last updated 2017-05-30
Locations	1 site in Spain

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Avanafil	Active comparator	Drug: Avanafil	Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).
Sildenafil	Active comparator	Drug: Sildenafil	Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil)

Avanafil (Drug), also known as no other interventions: Drug administration (Avanafil)
Sildenafil (Drug), also known as no other interventions: Drug administration (Sildenafil)

+Outcome measures

Primary outcomes

IIEF-EF [2 years]: Erectile Function Domain questionnaire of the International Index of Erectile Function.

Secondary outcomes

SLQQ-Part II [2 years]: Sexual life quality Questionnaire
GAQ [2 years]: Global Impression of efficacy

+Eligibility

Sex: Male, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Hospital Nacional de Paraplejicos	Toledo	Spain	Recruiting

My Notes

Public

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