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

Recruiting Phase 2 Interventional Study
Erectile Dysfunction (ED) Erectile Dysfunctions Erectile Function
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 75
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
83 (estimated)
Sponsor
Ryan Flannigan, MD · Other
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About This Trial
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…
Trial Locations
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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 adh…
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