A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age21-75
SponsorRyan Flannigan, MD
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 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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ST-04
Treatment groups
83 Participants
are divided into 1 treatment groupSponsors and collaborators
Ryan Flannigan, MD
Lead sponsor
University of British Columbia
Sponsor institution
Source ClinicalTrials.gov