Clinical trial NCT00507286: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Keogh Institute for Medical Research
Sponsor class: OTHER
First posted: 2007-07-26
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sexual Encounter Profile SEP2 and SEP3
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
state: Western Australia
Study officials:
affiliation: Keogh Institute for Medical Research
name: Bronwyn G STUCKEY, MBBS,FRACP
role: PRINCIPAL_INVESTIGATOR
References: