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

NCT00507286 | Unknown DMC

• 2 other identifiers: Protocol No. 2005-166Australia CTN: 2007/288
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Sexual Encounter Profile SEP2 and SEP3

Interventions

combination of various doses of sildenefil and alprostadil DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Keogh Institute for Medical Research: lead

Study Sites (1)

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

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bronwyn G STUCKEY, MBBS,FRACP

  Keogh Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2007-07

Locations

AU (1)