Avanafil Versus Sildenafil in Spinal Cord Injury Erectile... | NCT03169582

Studies
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction

NCT03169582

Sponsor

Eduardo Vargas-Baquero

Status

Unknown status

Last Update Posted

May 30, 2017Actual

Enrollment

78Estimated

Phase

Phase 4

Conditions

Erectile Dysfunction

Interventions

Avanafil
Sildenafil

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Jun 1, 2018Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Apr 21, 2017

First Submission Date that Met QC Criteria

May 26, 2017

First Posted Date

May 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2017

Last Update Posted Date

May 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eduardo Vargas-Baquero, Principal Investigator, Hospital Nacional de Parapléjicos de ToledoSponsor-Investigator

Lead Sponsor

Eduardo Vargas-BaqueroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Avanafil	Drug	Drug administration (Avanafil)	Avanafil	no other interventions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IIEF-EF	Erectile Function Domain questionnaire of the International Index of Erectile Function.	2 years

Secondary Outcomes

Measure	Description	Time Frame
SLQQ-Part II	Sexual life quality Questionnaire	2 years
GAQ	Global Impression of efficacy	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eduardo Vargas-Baquero, MD	Contact	+34925247700	47748	edua33@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Nacional de Paraplejicos	Recruiting	Toledo		45071	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C553414	avanafil
D000068677	Sildenafil Citrate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided