Combining Botulinum Toxin A and Tadalafil for Diabetic Men with Erectile Dysfunction
Official title: Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction Not Responding to Approved Oral or Intracorporeal Vasoactive Treatments.
Run by Aswan University Hospital · NCT06583590 · Data updated 2026-11-12
This study is testing if combining a muscle relaxant with a common erectile dysfunction pill can help diabetic men who haven't found relief with regular treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | Men only |
| Enrollment | 32 (estimated) |
| Sponsor | Aswan University Hospital Academic / other |
| Locations | 1 site (Aswān, Aswan Governorate) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT06583590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult married men with controlled diabetes and severe erectile dysfunction unresponsive to approved pharmacological treatments.
✕Probably not a fit
Patients with cardiovascular diseases, unstable psychiatric conditions, or anatomical abnormalities affecting erectile function may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and effectiveness of combining Botulinum toxin A with oral Tadalafil in diabetic men suffering from erectile dysfunction that has not responded to standard treatments. A total of 32 male patients will be recruited from outpatient clinics at Cairo and Aswan Universities. Participants will undergo a series of assessments, including clinical examinations and questionnaires, before and after receiving the treatment over a three-month period. The study aims to determine the durability of the treatment's effects through various evaluation methods.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for diabetic men with erectile dysfunction who do not respond to existing therapies.
How similar studies have gone: While the combination of these treatments is innovative, similar approaches have shown promise in other studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Aswan University-Faculty of Medicine
Aswān, Aswan Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Hossam-Eldin Hosny Ahmed Awad, Professor
- Email: sombok@yahoo.com
- Phone: 01001666093
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Umbilical cord stem cell and exosome injections for diabetic erectile dysfunction
This will test whether injections of umbilical cord–derived mesenchymal stem cells or their exosomes into the penis can improve erections in men aged 25–75 with diabetes who haven't responded to standard ED medicines.
-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.