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

NCT01776320 | Withdrawn Phase 4

• 1 other identifier: 103243
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Topical Alprostadil

Outcome Measures

Primary Outcomes (1)

• The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.

  4 - 8weeks

Secondary Outcomes (1)

• Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.

  4 - 8 weeks

Study Arms (1)

VITAROS

EXPERIMENTAL

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

Drug: Alprostadil

Interventions

Alprostadil DRUG

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

Also known as: VITAROS

VITAROS

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• 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.

  PMID: 23170913 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Gerald Brock, MD

  St.Joseph's Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: January 28, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

CA (1)