Daily Avanafil for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374994
• Other study ID #: 0105643
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: September 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 10, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Avanafil 50 MG
Oral phosphodiesterase type 5 inhibitors
• Placebo oral tablet
lactose and maize starch, Egypt

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University.	Alexandria	Elazareta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

References & 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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measuring the degree of improvement in the IIEF-5 score	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
Primary	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
Primary	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
Primary	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	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.	After 4 weeks treatment
Secondary	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.	After 4 weeks treatment
Secondary	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.	After 4 weeks treatment