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| ID | Type | Description | Link |
|---|---|---|---|
| Australia CTN: 2007/288 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination of various doses of sildenefil and alprostadil | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Encounter Profile SEP2 and SEP3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bronwyn G STUCKEY, MBBS,FRACP | Keogh Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands | Perth | Western Australia | 6009 | Australia |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |