Erectile Dysfunction
Conditions
Keywords
erectile dysfunction, endothelial dysfunction, Avanafil
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.
Interventions
DRUGAvanafil 50 MG
Oral phosphodiesterase type 5 inhibitors
DRUGPlacebo oral tablet
lactose and maize starch, Egypt
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of change of ET1 serum level from baseline to 4 weeks | 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 |
| The percentage of change of NO serum level from baseline to 4 weeks | 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 |
| The percentage of change of cGMP serum level from baseline to 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline. | 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. |
| Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline. | 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. |
| Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measuring the degree of improvement in the IIEF-5 score | 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 |
Countries
Egypt
Outcome results
None listed