A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction (NCT07601646)
Phase 2 Clinical Trial of ST-04 Intraurethral Paste for Erectile Dysfunction
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Vancouver Prostate Centre — Vancouver, British Columbia
Age range: 21 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Vancouver Prostate Centre — Vancouver, British Columbia
📞 Contact the Study Coordinator
Phone: (604) 875-4111
Email: clinicaltrials@prostatecentre.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Erectile Dysfunction (ED)
- IPP Placement & Intracavernosal Block — Winston-Salem, North Carolina
- Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction — Coral Gables, Florida
Explore by condition: All Erectile Dysfunction (ED) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.