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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
ST-04 consists of an alprostadil polymer suspension designed for intraurethral application
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
RECRUITINGChange from Baseline in the Erectile Function Domain of the IIEF Questionnaire
The IIEF is a validated questionnaire assessing erectile function, with total scores ranging from 5 to 25; higher scores indicate better erectile function
Time frame: From baseline to 1 month after start of the last dose level (Week 4, 8, 12 respectively)
Change from Baseline in the Erectile Hardness Scale (EHS)
The EHS is a self-reported assessment of penile hardness on a scale of 0 (no engorgement) to 4 (complete rigidity).
Time frame: From baseline to the end of treatment at week 4, 8 or 12 respectively
Change from Baseline in the Sexual Encounter Profile (SEP)
SEP is a log diary completed after each sexual attempt, providing information as to whether the erection was hard enough to penetrate (SEP 2), or whether it was maintained for completion (SEP 3).
Time frame: From baseline to the end of treatment at week 4, 8 or 12 respectively
Percentage of Uses per Participant of ST-04 which Led to the Onset of Erection within up to 30 minutes of Application per Number of Intercourse Attempts
Percentage of participants using ST-04 that could achieve an erection and/or penetrative intercourse within 30 minutes of application per number of intercourse attempts.
Time frame: From baseline to the end of treatment at week 4, 8 or 12 respectively
Incidence and Severity of Adverse events
Adverse events will be recorded at each follow-up visit and classified by type, severity, and relationship to the intervention.
Time frame: From baseline to the end of treatment at week 4, 8 or 12 respectively
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