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Completed

NCT Number: NCT04374994

Daily Avanafil for Erectile Dysfunction

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Alexandria University.

Alexandria, Elazareta, 21500, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avanafil 50 MG

Drug

Oral phosphodiesterase type 5 inhibitors

Placebo oral tablet

Drug

lactose and maize starch, Egypt

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 5, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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