Recruiting
Phase 2

ST-04

Sponsor:

Ryan Flannigan, MD

Code:

NCT07601646

Conditions

Erectile Dysfunction (ED)

Erectile Dysfunctions

Erectile Function

Eligibility Criteria

Sex: Male

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

ST-04

Study Details

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.

Conditions

Erectile Dysfunction (ED)

Erectile Dysfunctions

Erectile Function

Study ID

NCT07601646

Start date

May, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

83 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

ST-04

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

Primary outcome measure

  • Change from Baseline in the Erectile Function Domain of the IIEF Questionnaire [ Time Frame: From baseline to 1 month after start of the last dose level (Week 4, 8, 12 respectively) ]

Central Contacts and Locations

Locations

Vancouver Prostate Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Genevive - Clinical Trials Coordinator

604-875-4111clinicaltrials@prostatecentre.com

Principal Investigator:

Ryan Flannigan, MD

More Information

Sponsor

Ryan Flannigan, MD

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Erectile Dysfunction
  • Erectile Function
  • Alprostadil
  • Sildenafil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ryan Flannigan, MD on 2026-05-22.