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Tests treatment safety and results for Erectile Dysfunction With Diabetes Mellitus
Official title Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
ClinicalTrials.gov ID: NCT06583590
What this study is testing
What is Botulinum toxin A?
Botulinum toxin A is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for erectile dysfunction with diabetes mellitus.
Also referred to as Botox, BTX-A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, men only
You may be able to join if
- 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...
- Severe erectile dysfunction (erection hardness score ≤ E3 after intracavernosal injection of PGE-1).
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aswān, Aswan Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aswān, Aswan Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.