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.|
|ClinicalTrials.gov 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
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|
|Intervention Model:||Crossover Assignment|
|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|
- Sexual Encounter Profile SEP2 and SEP3
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 ClinicalTrials.gov 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|
|Principal Investigator:||Bronwyn G STUCKEY, MBBS,FRACP||Keogh Institute for Medical Research|