Intraurethral Alprostadil Paste for Erectile Dysfunction: Dose-Escalation Study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-arm, dose-escalation trial evaluating ST-04, a mucoadhesive intraurethral formulation of alprostadil. Participants may receive up to three dose levels over 12 weeks, with up to 11 administrations, and may use sildenafil in combination. The study aims to determine whether ST-04 can improve erectile function from baseline in adult men with ED. Eligible participants must have a confirmed ED diagnosis for more than three months and have failed PDE5 inhibitor therapy. The trial is conducted at the Vancouver Prostate Centre in British Columbia and is led by Dr. Ryan Flannigan.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have had a confirmed clinical diagnosis of ED for more than three months based upon IIEF
* Have failed PDE5 inhibitor therapy (inability to achieve an erection with adequate rigidity to allow penetrative sex)
* Ability to take oral medication (sildenafil) and be willing to adhere to the study intervention regimen
* Engaged in heterosexual relationship with partner for a minimum of 6 months

Exclusion Criteria:

* History of unstable medical or psychiatric condition that, in the opinion of the principal investigator, could impact the patient's ability to complete the study investigations or protocol.
* Spinal cord injury, or penile anatomical abnormalities
* Cardiovascular conditions that prevent sexual activity (NYHA Class II or higher, any angina, or uncontrolled CHF or severe coronary artery disease)
* History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study
* Use of anti-androgens, or oral or injectable androgens
* Documented hypotension or known orthostatic hypotension
* Use of oral, topical or sublingual nitrates within 3 months prior to enrollment into the study
* Hepatic (Child-Pugh Class C) or renal failure (eGFR \< 30)
* Inadequate response to intracavernosal injection therapy previously
* Peyronie's disease or Meatal stenosis

Where it's running

• Vancouver Prostate Centre
  Vancouver, British Columbia, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.