Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

NCT ID: NCT03169582

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-06-01

Brief Summary

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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

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

non- inferiority, randomized, crossover, open clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avanafil

Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil).

Group Type ACTIVE_COMPARATOR

Avanafil

Intervention Type DRUG

Drug administration (Avanafil)

Sildenafil

Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil)

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

Drug administration (Sildenafil)

Interventions

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Avanafil

Drug administration (Avanafil)

Intervention Type DRUG

Sildenafil

Drug administration (Sildenafil)

Intervention Type DRUG

Other Intervention Names

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no other interventions no other interventions

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eduardo Vargas-Baquero

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Vargas-Baquero

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Nacional de Paraplejicos

Toledo, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Eduardo Vargas-Baquero, MD

Role: CONTACT

+34925247700 ext. 47748

Facility Contacts

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Eduardo Vargas-Baquero, MD

Role: primary

Other Identifiers

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HNParaplejicos

Identifier Type: -

Identifier Source: org_study_id

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