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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Arm Dose Escalation | Experimental | Dose Level 1 is 500 μg of ST-04; Dose Level 2 is 1000 μg of ST-04 with or without Sildenafil; Dose Level 3 is 1500 μg of ST-04 with or without Sildenafil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-04 | Drug | ST-04 consists of an alprostadil polymer suspension designed for intraurethral application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to 1 month after start of the last dose level (Week 4, 8, 12 respectively) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to the end of treatment at week 4, 8 or 12 respectively |
| Change from Baseline in the Sexual Encounter Profile (SEP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Prostate Centre | Recruiting | Vancouver | British Columbia | V5Z1M9 | Canada |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Single-Arm, Dose Escalation
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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). |
| 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. | 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. | From baseline to the end of treatment at week 4, 8 or 12 respectively |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |