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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507286
Recruitment Status : Unknown
Verified July 2007 by Keogh Institute for Medical Research.
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2007
Last Update Posted : January 28, 2009
Information provided by:
Keogh Institute for Medical Research

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: combination of various doses of sildenefil and alprostadil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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.
Study Start Date : May 2007
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Primary Outcome Measures :
  1. Sexual Encounter Profile SEP2 and SEP3

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507286

Australia, Western Australia
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Keogh Institute for Medical Research
Principal Investigator: Bronwyn G STUCKEY, MBBS,FRACP Keogh Institute for Medical Research

Responsible Party: Professor Bronwyn Stuckey, Keogh Institute for Medical Research Identifier: NCT00507286     History of Changes
Other Study ID Numbers: Protocol No. 2005-166
Australia CTN: 2007/288
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: July 2007

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents