Daily Avanafil for Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04374994
- Lead Sponsor
- University of Alexandria
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 70
- Men with clinical diagnosis of erectile dysfunction of any severity.
- Should be associated with systemic disorders indicative of endothelial dysfunction
- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Placebo oral tablet Males with sexual dysfunction who received daily placebo tablets for four weeks intervention group Avanafil 50 MG Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Faculty of Medicine, Alexandria University.
🇪🇬Alexandria, Elazareta, Egypt