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

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Alprostadil

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