Daily Avanafil for Erectile Dysfunction

September 14, 2020 updated by: Shimaa Ismail Abdelhamid, MD, University of Alexandria

Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor (PDE5-I) . However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the erectile function and endothelial markers' serum level. In this work we recruited males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction. The investigators randomly treated patients with daily oral avanafil and the other patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of markers of endothelial function at baseline and treatment.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elazareta
      • Alexandria, Elazareta, Egypt, 21500
        • Faculty of Medicine, Alexandria University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention group
Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks
Drug: Avanafil 50 MG
Oral phosphodiesterase type 5 inhibitors
Placebo Comparator: control group
Males with sexual dysfunction who received daily placebo tablets for four weeks
Drug: Placebo oral tablet
lactose and maize starch, Egypt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of change of NO serum level from baseline to 4 weeks
Time Frame: After 4 weeks treatment
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
Time Frame: After 4 weeks treatment
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
Time Frame: After 4 weeks treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.
Time Frame: After 4 weeks treatment
To compare avanafil with placebo group regarding post-treatment nitric oxide (NO) (in µmol/L) serum level 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.
Time Frame: After 4 weeks treatment
To compare avanafil with placebo group regarding posttreatment cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level 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.
Time Frame: After 4 weeks treatment
To compare avanafil with placebo group regarding post-treatment endothelin-1 (ET1) (in ng/L) serum level and percentage of change from baseline.
After 4 weeks treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the degree of improvement in the IIEF-5 score
Time Frame: After 4 weeks treatment
The ED male's clinical response to daily avanafil was subjectively assessed by measuring the degree of improvement in the International Index of Erectile Function scoring (IIEF-5 ) score
After 4 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Investigators

  • Study Director: Abdelaal Elkamshoushi, MD, University of Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

April 15, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0105643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Because we will publish the study in a journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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