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

NCT ID: NCT01776320

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VITAROS

VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks

Group Type: EXPERIMENTAL

Alprostadil

Intervention Type: DRUG

One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.

Interventions

Alprostadil

One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.

Intervention Type: DRUG

Other Intervention Names

VITAROS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Gerald Brock

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Brock, MD

Role: PRINCIPAL_INVESTIGATOR

St.Joseph's Health Care

Locations

St. Joseph's Health Care London

London, Ontario, Canada

Countries

Canada

References

Costa P, Potempa AJ. Intraurethral alprostadil for erectile dysfunction: a review of the literature. Drugs. 2012 Dec 3;72(17):2243-54. doi: 10.2165/11641380-000000000-00000.

Reference Type: BACKGROUND

PMID: 23170913 (View on PubMed)

Other Identifiers

103243

Identifier Type: -

Identifier Source: org_study_id