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Daily Avanafil for Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Avanafil 50 MG
Placebo oral tablet
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring erectile dysfunction, endothelial dysfunction, Avanafil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Alexandria University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2020
Last Updated
September 14, 2020
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT04374994
Brief Title
Daily Avanafil for Erectile Dysfunction
Official Title
Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
erectile dysfunction, endothelial dysfunction, Avanafil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Males with sexual dysfunction who received daily placebo tablets for four weeks
Intervention Type
Drug
Intervention Name(s)
Avanafil 50 MG
Intervention Description
Oral phosphodiesterase type 5 inhibitors
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
lactose and maize starch, Egypt
Primary Outcome Measure Information:
Title
The percentage of change of NO serum level from baseline to 4 weeks
Description
To calculate the percentage of change of Nitric oxide (NO)(in µmol/L) serum level from baseline to 4 weeks post-treatment with avanafil
Time Frame
After 4 weeks treatment
Title
The percentage of change of cGMP serum level from baseline to 4 weeks
Description
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
Time Frame
After 4 weeks treatment
Title
The percentage of change of ET1 serum level from baseline to 4 weeks
Description
To calculate the percentage of change of endothelin-1 (ET1) (in ng/L) serum level from baseline to 4 weeks post-treatment with avanafil
Time Frame
After 4 weeks treatment
Secondary Outcome Measure Information:
Title
Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.
Description
To compare avanafil with placebo group regarding post-treatment nitric oxide (NO) (in µmol/L) serum level and percentage of change from baseline.
Time Frame
After 4 weeks treatment
Title
Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline.
Description
To compare avanafil with placebo group regarding posttreatment cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level and percentage of change from baseline.
Time Frame
After 4 weeks treatment
Title
Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline.
Description
To compare avanafil with placebo group regarding post-treatment endothelin-1 (ET1) (in ng/L) serum level and percentage of change from baseline.
Time Frame
After 4 weeks treatment
Other Pre-specified Outcome Measures:
Title
Measuring the degree of improvement in the IIEF-5 score
Description
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
Time Frame
After 4 weeks treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelaal Elkamshoushi, MD
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University.
City
Alexandria
State/Province
Elazareta
ZIP/Postal Code
21500
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because we will publish the study in a journal
Citations:
PubMed Identifier
19236190
Citation
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.
Results Reference
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Daily Avanafil for Erectile Dysfunction

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