Erectile Dysfunction Clinical Trial
Official title:
Efficacy and Safety Study of Using Oral Sildenafil and Intracavernosal Alprostadil Injection as a Combined Pharmacotherapy for Men With Difficult to Treat Erectile Dysfunction.
Erectile dysfunction (ED or impotence) is a common medical condition affecting many men
world wide. The most commonly used treatment for ED are oral medications like Viagra
(sildenafil), Levitra (vardenafil) and Cialis (tadalafil). If these are not effective the
use of an injection into the penis (intracavernosal injection or ICI) is necessary. However
in some men neither of these therapies is successful.
Hypothesis: An adequate erection may be achieved in men with difficult-to-treat erectile
dysfunction, when they are treated with a therapy of combination of tablet and penile
injection, when a single treatment therapy has failed for these men.
Aim of the study is to test the safety and efficacy of a combination of Viagra and Caverjet
Impulse in a group of men who had failed to achieve an adequate response to the maximum
recommended dose of either Viagra, Cialis or Levitra and Caverjet Impulse, when these
treatments were used alone.
20 men with difficult to treat ED will be given oral medication, intracavernosal therapy or
the combination in a single-blind randomised study.
Informed consent will be signed prior to any study procedures being carried out. All
participants are 'blinded' to their study treatments. Participants who have satisfactory
response to any of the tablets or penile injections, will be excluded from the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
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