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

RECRUITINGPhase 2/3Sponsored by Aswan University Hospital
Actively Recruiting
PhasePhase 2/3
SponsorAswan University Hospital
Started2024-08-01
Est. completion2025-08-31
Eligibility
Age21 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06583590

Summary

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.

Eligibility

Age: 21 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

* Adult controlled diabetic married men who proved to be vasculogenic ED by Penile Duplex.
* Men who had shown an insufficient response for at least 3 months to the registered PDE5-Is at the highest approved dose, either on-demand or daily, or to PGE1 ICIs.
* Severe erectile dysfunction (erection hardness score ≤ E3 after intracavernosal injection of PGE-1).

Exclusion Criteria:

* Men who had cardiovascular disease interfering with sexual activity.
* Men with history of an unstable psychiatric conditions
* Presence of penile anatomical abnormalities that would significantly impair erectile function.
* History of spinal or pelvic radical surgery.

Conditions2

DiabetesErectile Dysfunction With Diabetes Mellitus

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