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

NCT ID: NCT00507286

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-12-31

Brief 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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

combination of various doses of sildenefil and alprostadil

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Keogh Institute for Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Keogh Institute for Medical Research

Principal Investigators

Bronwyn G STUCKEY, MBBS,FRACP

Role: PRINCIPAL_INVESTIGATOR

Keogh Institute for Medical Research

Locations

Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

Australia CTN: 2007/288

Identifier Type: -

Identifier Source: secondary_id

Protocol No. 2005-166

Identifier Type: -

Identifier Source: org_study_id