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A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
Sponsor: Ryan Flannigan, MD
Summary
This is a single arm dose escalation trial of a mucoadhesive intraurethral polymer suspension of alprostadil (ST-04) and will investigate the efficacy of 3 dose levels of ST-04 in adult males with a clinical diagnosis of Erectile Dysfunction (ED). This study aims to determine if ST-04, with or without sildenafil, will improve erectile function (EF) compared to baseline. Participants in this study will receive ST-04, a new formulation containing the vasodilator, alprostadil which is known to be an effective drug in treating erectile dysfunction. ST-04 will be dispersed along the urethra, forming a hydrogel which adheres to the lining of the urethra with the goal of penile tumescence and erection. Participants may receive up to 3 dose level escalations of ST-04 over a 12-week period, for a total of up to 11 administrations of ST-04. Dose escalation may also be done with and without sildenafil.
Official title: Phase 2 Clinical Trial of ST-04 Intraurethral Paste for Erectile Dysfunction
Key Details
Gender
MALE
Age Range
21 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2026-05
Completion Date
2027-05
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
ST-04
ST-04 consists of an alprostadil polymer suspension designed for intraurethral application
Locations (1)
Vancouver Prostate Centre
Vancouver, British Columbia, Canada