Actively Recruiting
Phase 2 Clinical Trial of ST-04 Intraurethral Paste for Erectile Dysfunction
Led by Ryan Flannigan, MD · Updated on 2026-05-22
83
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called ST-04, a mucoadhesive intraurethral polymer suspension of alprostadil, for adult males with erectile dysfunction (ED). This Phase 2 trial aims to assess the effectiveness of three different dose levels of ST-04, with or without sildenafil, to improve erectile function compared to the participants' baseline. ST-04 is designed to deliver alprostadil directly inside the urethra to promote penile tumescence and erection. Participants will receive up to three escalating doses of ST-04 over a 12-week period, with a maximum of 11 administrations. Dose levels include 500 mcg, 1000 mcg, and 1500 mcg of ST-04, which may be given with or without sildenafil. Each dose is dispersed along the urethra forming a hydrogel that adheres to the lining to achieve its effect. During the study, participants will undergo assessments including the International Index of Erectile Function (IIEF) questionnaire to measure changes in erectile function at baseline and 1 month after each dose level. Additional evaluations include the Erectile Hardness Scale, Sexual Encounter Profile, and the percentage of successful erection onset within 30 minutes of application. Safety will be monitored through the recording of adverse events. The total study duration includes up to 12 weeks of treatment with regular follow-up visits.
CONDITIONS
Brief Title
A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have had a confirmed clinical diagnosis of erectile dysfunction for more than three months based on the IIEF
- Have failed PDE5 inhibitor therapy due to inability to achieve an erection with adequate rigidity for penetrative sex
- Ability to take oral medication such as sildenafil and willingness to follow the study intervention regimen
- Engaged in a heterosexual relationship for a minimum of six months
- Male participants aged 21 to 75 years
You will not qualify if you...
- History of unstable medical or psychiatric conditions that may affect study completion
- Spinal cord injury or penile anatomical abnormalities
- Cardiovascular conditions preventing sexual activity such as NYHA Class II or higher, angina, uncontrolled congestive heart failure, or severe coronary artery disease
- History of myocardial infarction, stroke, or life-threatening arrhythmia within six months before enrollment
- Use of anti-androgens or oral/injectable androgens
- Documented or known orthostatic hypotension
- Use of oral, topical, or sublingual nitrates within three months before enrollment
- Hepatic failure classified as Child-Pugh Class C or renal failure with eGFR below 30
- Inadequate response to previous intracavernosal injection therapy
- Presence of Peyronie's disease or meatal stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks depending on dose level
Participants receive escalating doses of ST-04 intraurethral paste to evaluate its effectiveness and safety for erectile dysfunction.
Visits approximately every 4 weeks during treatment at Weeks 4, 8, and 12
Trial Site Locations
Total: 1 location
1
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z1M9
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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