NCT02845765

Brief Summary

The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2019

Enrollment Period

4.8 years

First QC Date

July 19, 2016

Last Update Submit

July 20, 2020

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionEDFundus OculiRetinal VascularizationInternational Index of Erectile Function QuestionnaireIIEFDynamic Vessel AnalyzerDVAPhosphodiesterase type 5 InhibitorPDE5Is

Outcome Measures

Primary Outcomes (1)

  • Static and dynamic retinal vessels diameter

    Analysis of the presence and prevalence of retinal vascularization alterations using Dynamic Vessel Analyzer (DVA) in patients with Erectile Dysfunction and in subject healthy volunteers.

    Baseline and after 6 month of therapy

Secondary Outcomes (1)

  • International Index of Erectile Function (IIEF) Questionnaire

    After 6 month of therapy

Study Arms (2)

Patients with erectile dysfunction

Patients with erectile dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual activity. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline and 6 months after therapy with Phosphodiesterase type 5 Inhibitor (PDE5I).

Device: Dynamic Vessel Analyzer (DVA)Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)

Subject healthy volunteers

Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline

Device: Dynamic Vessel Analyzer (DVA)

Interventions

Dynamic Vessel Analyzer (DVA)DEVICE
Patients with erectile dysfunctionSubject healthy volunteers
Phosphodiesterase type 5 Inhibitor (PDE5I)DRUG
Patients with erectile dysfunction

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* n. 40 patients with erectile dysfunction haracterized by the inability to develop or maintain an erection of the penis during sexual activity * n. 20 subject healthy volunteers without erectile dysfunction or ocular desease

You may qualify if:

  • Subjects with erectile dysfunction diagnosis (organic and psychogenic);
  • Subjects with Erectile Dysfunction diagnosis defined by IIEF score ≤ 25
  • Subjects with stable partner for at least 6 months and sexually active.
  • Subjects aged between 40 - 60 years;
  • Signature of informed consent for patients

You may not qualify if:

  • Subjects with ED secondary diagnosis to hormonal alterations (i.e. hypogonadism, hypo / hyperthyroidism, hyperprolactinemia);
  • Subjects with a diagnosis of ED post-traumatic and iatrogenic, since after pelvic surgery;
  • Subjects suffering from any ocular pathology that involves use of contact lenses and / or glasses;
  • Subjects smoking;
  • Individuals with uncontrolled systemic diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Phosphodiesterase 5 Inhibitors

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Phosphodiesterase InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Andrea Salonia, MD, PhD

    University Vita-Salute, San Raffaele Hospital - Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Querques, MD, PhD

CONTACT

+39 0226434004giuseppe.querques@hotmail.it

Roberta Scano

CONTACT

+39 0226435506scano.roberta@hsr.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head-Medical retina & Imaging unit

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 27, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 22, 2020

Record last verified: 2019-07

Locations

IT(1)