NCT03169582

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

April 21, 2017

Last Update Submit

May 26, 2017

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • IIEF-EF

    Erectile Function Domain questionnaire of the International Index of Erectile Function.

    2 years

Secondary Outcomes (2)

  • SLQQ-Part II

    2 years

  • GAQ

    2 years

Study Arms (2)

Avanafil

ACTIVE COMPARATOR

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

Drug: Avanafil

Sildenafil

ACTIVE COMPARATOR

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

Drug: Sildenafil

Interventions

AvanafilDRUG

Drug administration (Avanafil)

Also known as: no other interventions
Avanafil
SildenafilDRUG

Drug administration (Sildenafil)

Also known as: no other interventions
Sildenafil

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury
  • Erectile dysfunction
  • No Medical Contraindication to use Avanafil and/or Sildenafil
  • Able to provide informed consent
  • Able to complete questionnaires

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional de Paraplejicos

Toledo, 45071, Spain

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafilSildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Eduardo Vargas-Baquero, MD

CONTACT

+34925247700edua33@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: non- inferiority, randomized, crossover, open clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2017

First Posted

May 30, 2017

Study Start

April 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)