Daily Avanafil for Erectile Dysfunction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Avanafil 50 MG
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention group<br>Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks | Drug: Avanafil 50 MG<br>* Oral phosphodiesterase type 5 inhibitors<br>|
| Placebo Comparator: control group<br>Males with sexual dysfunction who received daily placebo tablets for four weeks | Drug: Placebo oral tablet<br>* lactose and maize starch, Egypt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, endothelial dysfunction, Avanafil