NCT05109377

Brief Summary

The investigators analyze the patients' endocan levels, IIEF scores, and hormon levels both before and after tadalafil (5 or 20mg) treatment. The investigators want to see erectile dysfunction severity and tadalafil treatment relations with endocen level.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

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

June 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

September 4, 2021

Last Update Submit

November 4, 2021

Conditions

Erectile Dysfunction

Keywords

EndocanErectile dysfunctionTadalafil

Outcome Measures

Primary Outcomes (1)

  • Rates of IIEF Score

    Levels of Endocan relationship with IIEF

    1 month

Secondary Outcomes (1)

  • Levels of Endocan

    1 month

Study Arms (2)

5mg tadalafil

OTHER

5mg tadalafil

Diagnostic Test: EndocanDrug: tadalafil

20mg tadalafil

OTHER

20 mg tadalafil

Diagnostic Test: EndocanDrug: tadalafil

Interventions

EndocanDIAGNOSTIC_TEST

Endocan will measured before and after treatment

20mg tadalafil5mg tadalafil
tadalafilDRUG

tadalafil

20mg tadalafil5mg tadalafil

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with erectile dysfuction

You may not qualify if:

  • Psychogenic erectile dysfunction
  • Erectile dysfunction associated with hormonal disorders
  • Drug related erectile dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veysel Bayburtluoğlu

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Veysel Bayburtluoğlu

    Ministry of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veysel Bayburtluoğlu

CONTACT

+905530299981bayburtluogluveysel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2021

First Posted

November 5, 2021

Study Start

June 24, 2021

Primary Completion

November 15, 2021

Study Completion

December 15, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Research data

Locations

TU(1)