Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00507286
• Other study ID #: Protocol No. 2005-166
• Secondary ID: Australia CTN: 2
• Status: Active, not recruiting
• Phase: N/A
• First received: July 25, 2007
• Last updated: January 27, 2009
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: July 2007
• Source: Keogh Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• combination of various doses of sildenefil and alprostadil

Locations

Country	Name	City	State
Australia	Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Keogh Institute for Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Encounter Profile SEP2 and SEP3