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A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction

RecruitingPhase 2Ages 21 Years - 75 YearsMaleRyan Flannigan, MD
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In plain words

What the trial is, and whether it could suit you

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 silden

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • ST-04
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Where

1 site
Vancouver Prostate Centre
Vancouver, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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