Erectile DysfunctionNCT00507286
Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
A study testing combination of various doses of sildenefil and alprostadil in people with Erectile Dysfunction, run by Keogh Institute for Medical Research at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- combination of various doses of sildenefil and alprostadil
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- May 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Perth, Western Australia, 6009
About this study
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.
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.
Read more
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
- Being tested
- combination of various doses of sildenefil and alprostadil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of various doses of sildenefil and alprostadilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Encounter Profile SEP2 and SEP3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keogh Institute for Medical Research
- Sponsor type
- University, hospital or other
- Investigators
- Bronwyn G STUCKEY, MBBS,FRACP, Principal investigator, Keogh Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507286
- Sponsor's protocol ID
- Protocol No. 2005-166
- Other IDs
- Australia CTN: 2007/288
- Status last verified
- Jul 2007
- First submitted
- 25 Jul 2007
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00507286
- Acronym / sponsor ID
- Protocol No. 2005-166
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Keogh Institute for Medical ResearchUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 26 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of various doses of sildenefil and alprostadil | Drug | – |
Primary outcome
Sexual Encounter Profile SEP2 and SEP3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronwyn G STUCKEY, MBBS,FRACP principal investigator
Keogh Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of various doses of sildenefil and alprostadil in people with Erectile Dysfunction, run by Keogh Institute for Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Encounter Profile SEP2 and SEP3. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009; AzTrials last refreshed its copy on 8 Nov 2026.