NCT04374994

Brief Summary

In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

April 27, 2020

Last Update Submit

September 14, 2020

Conditions

Erectile Dysfunction

Keywords

erectile dysfunctionendothelial dysfunctionAvanafil

Outcome Measures

Primary Outcomes (3)

  • The percentage of change of NO serum level from baseline to 4 weeks

    To calculate the percentage of change of Nitric oxide (NO)(in µmol/L) serum level from baseline to 4 weeks post-treatment with avanafil

    After 4 weeks treatment

  • The percentage of change of cGMP serum level from baseline to 4 weeks

    To calculate the percentage of change of cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level from baseline to 4 weeks post-treatment with avanafil

    After 4 weeks treatment

  • The percentage of change of ET1 serum level from baseline to 4 weeks

    To calculate the percentage of change of endothelin-1 (ET1) (in ng/L) serum level from baseline to 4 weeks post-treatment with avanafil

    After 4 weeks treatment

Secondary Outcomes (3)

  • Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.

    After 4 weeks treatment

  • Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline.

    After 4 weeks treatment

  • Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline.

    After 4 weeks treatment

Other Outcomes (1)

  • Measuring the degree of improvement in the IIEF-5 score

    After 4 weeks treatment

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks

Drug: Avanafil 50 MG

control group

PLACEBO COMPARATOR

Males with sexual dysfunction who received daily placebo tablets for four weeks

Drug: Placebo oral tablet

Interventions

Avanafil 50 MGDRUG

Oral phosphodiesterase type 5 inhibitors

intervention group
Placebo oral tabletDRUG

lactose and maize starch, Egypt

control group

Eligibility Criteria

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

You may qualify if:

  • Men with clinical diagnosis of erectile dysfunction of any severity.
  • Should be associated with systemic disorders indicative of endothelial dysfunction

You may not qualify if:

  • \- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University.

Alexandria, Elazareta, 21500, Egypt

Location

Related Publications (1)

  • Konstantinopoulos A, Giannitsas K, Athanasopoulos A, Spathas D, Perimenis P. The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction. Expert Opin Pharmacother. 2009 Feb;10(2):155-60. doi: 10.1517/14656560802678211.

    PMID: 19236190BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil

Condition Hierarchy (Ancestors)

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

Study Officials

  • Abdelaal Elkamshoushi, MD

    University of Alexandria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 5, 2020

Study Start

September 1, 2018

Primary Completion

April 15, 2019

Study Completion

October 10, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Because we will publish the study in a journal

Locations

EG(1)