Clinical trial NCT04374994: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: erectile dysfunction
endothelial dysfunction
Avanafil
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The percentage of change of NO serum level from baseline to 4 weeks
timeFrame: After 4 weeks treatment
measure: The percentage of change of cGMP serum level from baseline to 4 weeks
timeFrame: After 4 weeks treatment
measure: The percentage of change of ET1 serum level from baseline to 4 weeks
timeFrame: After 4 weeks treatment
Secondary outcomes:
measure: Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.
timeFrame: After 4 weeks treatment
measure: Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline.
timeFrame: After 4 weeks treatment
measure: Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline.
timeFrame: After 4 weeks treatment
Other outcomes:
measure: Measuring the degree of improvement in the IIEF-5 score
timeFrame: After 4 weeks treatment
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University.
state: Elazareta
Study officials:
affiliation: University of Alexandria
name: Abdelaal Elkamshoushi, MD
role: STUDY_DIRECTOR
References:
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.