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

Lawson Health Research Institute

Status and phase: Withdrawn; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: Alprostadil

Study type: Interventional

Funder types: Other

Identifiers

NCT01776320

103243

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

VITAROS

Experimental group

Description:

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

Treatment:

Drug: Alprostadil