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Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction

This study is not yet open for participant recruitment.
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Gerald Brock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01776320
First received: December 7, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of treatment. Patients with erectile problems will be given the approved drug Vitaros to treat their condition. They will be given forms and questionnaires to complete. The information collected will be used to assess the effectiveness, safety and the satisfaction levels with this drug.


Condition Intervention Phase
Erectile Dysfunction
 Drug: Alprostadil
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction.

Resource links provided by NLM:

Drug Information available for: Alprostadil
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores. [ Time Frame: 4 - 8weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction. [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VITAROS
VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks
 Drug: Alprostadil
One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.
Other Name: VITAROS

Detailed Description:

Transdermal topical alprostadil has been approved for use in Canada as a treatment for erectile dysfunction. However, as this form of treatment is new, and Canada is the first country in the world to approve its use. There are very few published articles in literature to evaluate its clinical acceptance. By performing a Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (transdermal topical alprostadil) in Men with Erectile Dysfunction, this study can improve understanding of this method of treatment as compared to conventional treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18y rs old and above
  • Has mild-to-moderate erectile dysfunction
  • Currently or previous treated for erectile dysfunction using PDE5 inhibitors, vacuum erection devices (VED), intra-cavernosal injections (ICI) and medical urethral system for erection (MUSE).
  • Sexually active
  • Has a regular sexual partner

Exclusion Criteria:

  • Known allergy to alprostadil
  • Unable to provide own informed consent
  • Unable to understand and complete a questionnaire in English
  • Unable to return for a post-treatment clinic evaluation
  • Regular sexual partner is unable to understand and complete a questionnaire in English
  • Sexual partner is a pregnant or lactating female
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776320

Contacts
Contact: Ling De Young, MD 519-646-6100 ext 61090 ling.deyoung@sjhc.london.on.ca

Locations
Canada, Ontario
St. Joseph's Health Care London Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Ling De Young, MD     519-646-6100 ext 61090     ling.deyoung@sjhc.london.on.ca    
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Gerald Brock, MD St.Joseph's Health Care
  More Information

Publications:

Responsible Party: Gerald Brock, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01776320     History of Changes
Other Study ID Numbers: 103243
Study First Received: December 7, 2012
Last Updated: January 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Erectile Dysfunction
Topical Alprostadil

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Erectile Dysfunction
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alprostadil
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013