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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Keogh Institute for Medical Research.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT00507286
First received: July 25, 2007
Last updated: January 27, 2009
Last verified: July 2007

July 25, 2007
January 27, 2009
May 2007
September 2008   (final data collection date for primary outcome measure)
Sexual Encounter Profile SEP2 and SEP3
Same as current
Complete list of historical versions of study NCT00507286 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of Combined Oral and Injection Therapy for Erectile Dysfunction
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.

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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Erectile Dysfunction
Drug: combination of various doses of sildenefil and alprostadil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2008
September 2008   (final data collection date for primary outcome measure)

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
Male
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00507286
Protocol No. 2005-166, Australia CTN: 2007/288
Yes
Professor Bronwyn Stuckey, Keogh Institute for Medical Research
Keogh Institute for Medical Research
Not Provided
Principal Investigator: Bronwyn G STUCKEY, MBBS,FRACP Keogh Institute for Medical Research
Keogh Institute for Medical Research
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP