Actively Recruiting

Phase 2
Phase 3
Age: 21Years +
MALE
NCT06583590

Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Led by Aswan University Hospital · Updated on 2024-12-03

32

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

A

Aswan University Hospital

Lead Sponsor

A

Aswan University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ICI) of Botulinum toxin A plus oral tadalafil in controlled diabetic men with refractory Erectile Dysfunction.

CONDITIONS

Official Title

Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Who Can Participate

Age: 21Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult controlled diabetic married men who have vasculogenic erectile dysfunction confirmed by Penile Duplex ultrasound
  • Men with insufficient response for at least 3 months to approved PDE5 inhibitors at the highest dose or to prostaglandin E1 intracavernosal injections
  • Severe erectile dysfunction with an erection hardness score of 3 or less after prostaglandin E1 injection
Not Eligible

You will not qualify if you...

  • Men with cardiovascular disease that interferes with sexual activity
  • Men with unstable psychiatric conditions
  • Presence of penile anatomical abnormalities significantly impairing erectile function
  • History of spinal or pelvic radical surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Aswan University-Faculty of Medicine

Aswān, Aswan Governorate, Egypt, 81528

Actively Recruiting

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Research Team

H

Hossam-Eldin Hosny Ahmed Awad, Professor

CONTACT

M

Moustafa Adam Ali, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction | DecenTrialz