A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
20. mai 2026 oppdatert av: Ryan Flannigan, MD
Phase 2 Clinical Trial of ST-04 Intraurethral Paste for Erectile Dysfunction
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
83
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z1M9
- Rekruttering
- Vancouver Prostate Centre
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Hovedetterforsker:
- Ryan Flannigan, MD
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Ta kontakt med:
- Genevive - Clinical Trials Coordinator
- Telefonnummer: 67898 604-875-4111
- E-post: clinicaltrials@prostatecentre.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Single-Arm Dose Escalation
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.
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ST-04 consists of an alprostadil polymer suspension designed for intraurethral application
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in the Erectile Function Domain of the IIEF Questionnaire
Tidsramme: From baseline to 1 month after start of the last dose level (Week 4, 8, 12 respectively)
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The IIEF is a validated questionnaire assessing erectile function, with total scores ranging from 5 to 25; higher scores indicate better erectile function
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From baseline to 1 month after start of the last dose level (Week 4, 8, 12 respectively)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in the Erectile Hardness Scale (EHS)
Tidsramme: From baseline to the end of treatment at week 4, 8 or 12 respectively
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The EHS is a self-reported assessment of penile hardness on a scale of 0 (no engorgement) to 4 (complete rigidity).
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From baseline to the end of treatment at week 4, 8 or 12 respectively
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Change from Baseline in the Sexual Encounter Profile (SEP)
Tidsramme: From baseline to the end of treatment at week 4, 8 or 12 respectively
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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).
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From baseline to the end of treatment at week 4, 8 or 12 respectively
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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
Tidsramme: From baseline to the end of treatment at week 4, 8 or 12 respectively
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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.
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From baseline to the end of treatment at week 4, 8 or 12 respectively
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Incidence and Severity of Adverse events
Tidsramme: From baseline to the end of treatment at week 4, 8 or 12 respectively
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Adverse events will be recorded at each follow-up visit and classified by type, severity, and relationship to the intervention.
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From baseline to the end of treatment at week 4, 8 or 12 respectively
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. april 2027
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
15. mai 2026
Først innsendt som oppfylte QC-kriteriene
15. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H25-00542
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