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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks |
|
| control group | Placebo Comparator | Males with sexual dysfunction who received daily placebo tablets for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avanafil 50 MG | Drug | Oral phosphodiesterase type 5 inhibitors |
| |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.
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| Name | Affiliation | Role |
|---|---|---|
| Abdelaal Elkamshoushi, MD | University of Alexandria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Alexandria University. | Alexandria | Elazareta | 21500 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19236190 | Background | 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. |
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Because we will publish the study in a journal
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2018 | May 6, 2020 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | May 6, 2020 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C553414 | avanafil |
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| Placebo oral tablet |
| Drug |
lactose and maize starch, Egypt |
|
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 |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |