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

ConditionsErectile Dysfunction (ED)Erectile DysfunctionsErectile Function
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • ST-04

    Drug

    ST-04 consists of an alprostadil polymer suspension designed for intraurethral application

Treatment groups

83 Participants
are divided into 1 treatment group
Group A: Single-Arm Dose EscalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change 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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ryan Flannigan, MD

Lead sponsor

University of British Columbia

Sponsor institution

Source ClinicalTrials.gov
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