Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
combination of various doses of sildenefil and alprostadil
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
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
Sites / Locations
- Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Outcomes
Primary Outcome Measures
Sexual Encounter Profile SEP2 and SEP3
Secondary Outcome Measures
Full Information
NCT ID
NCT00507286
First Posted
July 25, 2007
Last Updated
January 27, 2009
Sponsor
Keogh Institute for Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00507286
Brief Title
Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
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 Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Keogh Institute for Medical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
combination of various doses of sildenefil and alprostadil
Primary Outcome Measure Information:
Title
Sexual Encounter Profile SEP2 and SEP3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bronwyn G STUCKEY, MBBS,FRACP
Organizational Affiliation
Keogh Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
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Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
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