Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

Eduardo Vargas-Baquero

Status and phase: Unknown; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: Sildenafil; Drug: Avanafil

Study type: Interventional

Funder types: Other

Identifiers

NCT03169582

HNParaplejicos

Details and patient eligibility

About

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

Enrollment: 78 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Avanafil

Active Comparator group

Description:

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

Treatment:

Drug: Avanafil

Sildenafil

Active Comparator group

Description:

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

Treatment:

Drug: Sildenafil