NCT07601646 A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
| NCT ID | NCT07601646 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ryan Flannigan, MD |
| Condition | Erectile Dysfunction (ED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2026-05 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 83 participants in total. It began in 2026-05 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07601646 clinical trial?
This trial is open to male participants only, aged 21 Years or older, up to 75 Years, studying Erectile Dysfunction (ED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07601646 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07601646 currently recruiting?
Yes, NCT07601646 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ryan Flannigan, MD to inquire about joining.
Where is the NCT07601646 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT07601646 clinical trial?
NCT07601646 is sponsored by Ryan Flannigan, MD. The trial plans to enroll 83 participants.