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Daily Avanafil for Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT04374994
Recruitment Status : Completed
First Posted : May 5, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Shimaa Ismail Abdelhamid, 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, nitric oxide (NO), cyclic guanosine monophosphate (cGMP) and endothelin-1 (ET1) 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. The results revealed improvement in the serum levels of the markers and erectile function in avanafil treated group versus placebo after 4 week treatment.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Avanafil 50 MG Drug: Placebo oral tablet Phase 4

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 70 males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction like diabetes mellitus (DM), hypertension (HTN) and dyslipidemia. The investigators randomly treated 70 patients with 50mg daily oral avanafil and the other 70 patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of endothelin-1 (ET1), nitric oxide (NO) and cyclic guanosine monophosphate (cGMP) as markers of endothelial function at baseline and after four weeks treatment. At the end of study, the participants randomized to avanafil achieved statistically significant improvement in erectile function, endothelin-1, nitric oxide and cyclic guanosine monophosphate levels from baseline versus placebo regardless the type and duration of associated comorbidity, the duration and severity of erectile dysfunction. These results permitted the investigators to conclude that daily avanafil is effective in treatment of patients with erectile dysfunction and impaired endothelial function.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
Active Comparator: intervention group
Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks
Drug: Avanafil 50 MG
Oral phosphodiesterase type 5 inhibitors

Placebo Comparator: control group
Males with sexual dysfunction who received daily placebo tablets for four weeks
Drug: Placebo oral tablet
lactose 25%, maize starch 5%, magnesium stearate 1%, and microcrystalline cellulose 69%, Egypt




Primary Outcome Measures :
  1. The percentage of change of NO serum level from baseline to 4 weeks [ Time Frame: 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

  2. The percentage of change of cGMP serum level from baseline to 4 weeks [ Time Frame: 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

  3. The percentage of change of ET1 serum level from baseline to 4 weeks [ Time Frame: 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 :
  1. Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline. [ Time Frame: 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.

  2. Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline. [ Time Frame: 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.

  3. Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline. [ Time Frame: 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.


Other Outcome Measures:
  1. Measuring the degree of improvement in the IIEF-5 score [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with clinical diagnosis of erectile dysfunction of any severity.
  • Should be associated with systemic disorders indicative of endothelial dysfunction such as diabetes mellitus , dyslipidemia and/or hypertension

Exclusion Criteria:

  • Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.
  • Leukemia and
  • Multiple myeloma
  • nitrates or anticoagulants intake.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374994


Locations
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Egypt
Faculty of Medicine, Alexandria University.
Alexandria, Elazareta, Egypt, 21500
Sponsors and Collaborators
University of Alexandria
Investigators
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Study Director: Abdelaal Elkamshoushi, MD University of Alexandria
  Study Documents (Full-Text)

Documents provided by Shimaa Ismail Abdelhamid, University of Alexandria:
Study Protocol  [PDF] September 20, 2018
Statistical Analysis Plan  [PDF] September 20, 2018

Publications:
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Responsible Party: Shimaa Ismail Abdelhamid, Principal investigator, University of Alexandria
ClinicalTrials.gov Identifier: NCT04374994    
Other Study ID Numbers: 0105643
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Because we will publish the study in a journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shimaa Ismail Abdelhamid, University of Alexandria:
erectile dysfunction
endothelial dysfunction
Avanafil
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders