Daily Avanafil for Erectile Dysfunction

NCT ID: NCT04374994

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-10-10

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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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intervention group

Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks

Group Type ACTIVE_COMPARATOR

Avanafil 50 MG

Intervention Type DRUG

Oral phosphodiesterase type 5 inhibitors

control group

Males with sexual dysfunction who received daily placebo tablets for four weeks

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

lactose and maize starch, Egypt

Interventions

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Avanafil 50 MG

Oral phosphodiesterase type 5 inhibitors

Intervention Type DRUG

Placebo oral tablet

lactose and maize starch, Egypt

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Ismail Abdelhamid, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelaal Elkamshoushi, MD

Role: STUDY_DIRECTOR

University of Alexandria

Locations

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Faculty of Medicine, Alexandria University.

Alexandria, Elazareta, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 19236190 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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0105643

Identifier Type: -

Identifier Source: org_study_id

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