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

U.S., May 23 -- ClinicalTrials.gov registry received information related to the study (NCT07601646) titled 'A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction' on May 15.

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 ...