Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction

Keogh Institute for Medical Research

Status

Unknown

Conditions

Erectile Dysfunction

Treatments

Drug: combination of various doses of sildenefil and alprostadil

Study type

Interventional

Funder types

Other

Identifiers

NCT00507286

Protocol No. 2005-166

Australia CTN: 2007/288

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men aged 20 years and over
History of ED for at least 6 months
IIEF score <26
Failure to achieve an adequate response to the maximum recommended therapeutic dose of an approved ED treatments, when either of these treatments was used alone.

Exclusion criteria

Concurrent treatment with nitrate-containing medications
Significant cardiac, hepatic, renal or respiratory dysfunction
Systolic blood pressure of less than 100mm Hg
Myocardial infarction, serious cardiac arrhythmia, cardiac surgery, or stroke within the last 6 months
Significant penile fibrosis, curvature or infection
Reported significant side effects of using PDE5 inhibitors or alprostadil
Hypersensitivity to PDE5 inhibitors or alprostadil