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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00507286




Registration number
NCT00507286
Ethics application status
Date submitted
25/07/2007
Date registered
26/07/2007
Date last updated
28/01/2009

Titles & IDs
Public title
Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
Scientific 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.
Secondary ID [1] 0 0
Australia CTN: 2007/288
Secondary ID [2] 0 0
Protocol No. 2005-166
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile Dysfunction 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - combination of various doses of sildenefil and alprostadil

Treatment: Drugs: combination of various doses of sildenefil and alprostadil
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sexual Encounter Profile SEP2 and SEP3
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2008
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Keogh Institute for Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00507286
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn G STUCKEY, MBBS,FRACP
Address 0 0
Keogh Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00507286