Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age21+
SponsorAswan University Hospital
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Botulinum toxin A
- Tadalafil 5mg
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov