A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction
2026年5月20日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
83
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z1M9
- 招聘中
- Vancouver Prostate Centre
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首席研究员：
- Ryan Flannigan, MD
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接触：
- Genevive - Clinical Trials Coordinator
- 电话号码：67898 604-875-4111
- 邮箱：clinicaltrials@prostatecentre.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in the Erectile Function Domain of the IIEF Questionnaire
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in the Erectile Hardness Scale (EHS)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年5月15日
首先提交符合 QC 标准的
2026年5月15日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月20日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.