A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
Recruiting
Phase 2
Interventional Study
Erectile Dysfunction (ED)
Erectile Dysfunctions
Erectile Function
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 – 75
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 83 (estimated)
- Sponsor
- Ryan Flannigan, MD · Other
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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…
Trial Locations
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Eligibility Criteria
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 adh…
Contacts
No contact information available.