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

Phase 4

Withdrawn

• Conditions: Erectile Dysfunction
• Interventions: Drug: Alprostadil

• Registration Number: NCT01776320
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Study Start: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-04
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.	4 - 8weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.	4 - 8 weeks

Trial Locations

Locations (1)

St. Joseph's Health Care London; 🇨🇦 London, Ontario, Canada