Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
Status:
Unknown status
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
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.