Erectile Dysfunction (ED), Erectile Dysfunctions, Erectile Function
Conditions
Keywords
Erectile Dysfunction, Erectile Function, Alprostadil, Sildenafil
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 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.
Interventions
DRUGST-04
ST-04 consists of an alprostadil polymer suspension designed for intraurethral application
Sponsors
Ryan Flannigan, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-Arm, Dose Escalation
Eligibility
Sex/Gender
MALE
Age
21 Years to 75 Years
Healthy volunteers
No
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 adhere to the study intervention regimen * Engaged in heterosexual relationship with partner for a minimum of 6 months
Exclusion criteria
* 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 * Use of anti-androgens, or oral or injectable androgens * Documented hypotension or known orthostatic hypotension * Use of oral, topical or sublingual nitrates within 3 months prior to enrollment into the study * Hepatic (Child-Pugh Class C) or renal failure (eGFR \< 30) * Inadequate response to intracavernosal injection therapy previously * Peyronie's disease or Meatal stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Erectile Function Domain of the IIEF Questionnaire | From baseline to 1 month after start of the last dose level (Week 4, 8, 12 respectively) | The IIEF is a validated questionnaire assessing erectile function, with total scores ranging from 5 to 25; higher scores indicate better erectile function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Erectile Hardness Scale (EHS) | From baseline to the end of treatment at week 4, 8 or 12 respectively | The EHS is a self-reported assessment of penile hardness on a scale of 0 (no engorgement) to 4 (complete rigidity). |
| Change from Baseline in the Sexual Encounter Profile (SEP) | From baseline to the end of treatment at week 4, 8 or 12 respectively | 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). |
| 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 | From baseline to the end of treatment at week 4, 8 or 12 respectively | 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. |
| Incidence and Severity of Adverse events | From baseline to the end of treatment at week 4, 8 or 12 respectively | Adverse events will be recorded at each follow-up visit and classified by type, severity, and relationship to the intervention. |
Countries
Canada
Outcome results
None listed