Endothelial Markers and Tadalafil Response
2026年8月19日 更新者：Abul-fotouh Ahmed、Al-Azhar University
Endothelial Dysfunction Markers as Predictors of Clinical Response to Daily Tadalafil in Men With Vasculogenic Erectile Dysfunction
This prospective cohort study will recruit eligible men attending the Urology/Andrology outpatient clinic.
Baseline assessment will include demographic and clinical data, cardiovascular risk assessment, erectile-function questionnaires, routine laboratory investigations, brachial artery flow-mediated dilatation, carotid intima-media thickness, and selected circulating endothelial biomarkers including endothelin-1, nitrite/nitrate, high-sensitivity C-reactive protein, soluble vascular cell adhesion molecule-1, and soluble intercellular adhesion molecule-1.
All participants will receive tadalafil 5 mg once daily for 12 weeks.
Erectile function, adherence, and adverse events will be assessed during follow-up.
The primary outcome will be clinical response at 12 weeks, defined as an improvement of at least 4 points in the IIEF-EF domain together with a positive response to the Global Assessment Question.
研究概览
详细说明
Erectile dysfunction is a common male sexual disorder and is often associated with endothelial dysfunction, impaired nitric oxide bioavailability, inflammation, arterial stiffness, and subclinical atherosclerosis. Because penile arteries are relatively small, vasculogenic erectile dysfunction may appear before overt cardiovascular disease. Brachial artery flow-mediated dilatation reflects endothelial-dependent vasodilation, carotid intima-media thickness reflects structural vascular change, and circulating endothelial biomarkers may provide additional information about endothelial injury and inflammation.
This prospective observational cohort study will recruit men with predominantly vasculogenic erectile dysfunction attending the Urology/Andrology outpatient clinic. Baseline demographic, clinical, sexual, laboratory, vascular, and biomarker data will be collected before treatment. All participants will receive tadalafil 5 mg once daily for 12 weeks. Erectile function will be measured again at follow-up using the IIEF-EF domain, IIEF-5/SHIM, and the Global Assessment Question. The primary outcome is clinical response at 12 weeks, defined as an improvement of at least 4 points in IIEF-EF together with a positive Global Assessment Question response. The study will also evaluate whether baseline endothelial dysfunction markers improve prediction of tadalafil response beyond standard clinical variables.
研究类型
观察性的
注册 (估计的)
120
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。
学习联系方式
- 姓名：Abul-fotouh Ahmed
- 电话号码：+201001066756
- 邮箱：abulfotouhahmed@yahoo.com
学习地点
-
-
-
Cairo、埃及
- 招聘中
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
-
接触：
- Abul-fotouh Ahmed
- 电话号码：+201001066756
- 邮箱：abulfotouhahmed@yahoo.com
-
-
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
取样方法
非概率样本
研究人群
Consecutive adult men with predominantly vasculogenic erectile dysfunction presenting to the Urology/Andrology outpatient clinic at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt, aged 30 to 70 years and eligible for tadalafil 5 mg once daily.
描述
Inclusion Criteria:
Participants must fulfill all of the following:
- Men aged 30 to 70 years.
- ED lasting at least 3 months.
- IIEF-5/SHIM score of 21 or less or clinically documented ED.
- Clinical features suggesting predominantly vasculogenic ED.
- Sexually active or willing to attempt sexual intercourse during the study.
- Able to complete the study questionnaires.
- Willing to take tadalafil 5 mg once daily for 12 weeks.
- Able to provide written informed consent.
- Willing to avoid other ED treatments during the study unless medically necessary.
Exclusion Criteria:
Patients will be excluded if they have:
- ED primarily attributed to psychogenic causes.
- Predominantly neurogenic ED.
- Severe untreated hypogonadism likely to be the primary cause of ED.
- Untreated hyperprolactinemia or another major endocrine disorder.
- Significant penile anatomical abnormality interfering with intercourse, including severe Peyronie's disease.
- Previous radical pelvic surgery or pelvic radiotherapy.
- Active urinary or genital infection.
- Unstable angina or unstable cardiovascular disease.
- Recent myocardial infarction or stroke.
- Uncontrolled hypertension or clinically significant hypotension.
- Severe renal impairment requiring an alternative tadalafil regimen.
- Severe hepatic impairment.
- Active malignancy or expected survival of less than one year.
- Major psychiatric illness, cognitive impairment or inability to comply with follow-up.
- Current use of another PDE5 inhibitor or intracavernosal therapy that cannot be discontinued.
- Concomitant use of organic nitrates, nitric oxide donors or nicorandil.
- Known hypersensitivity to tadalafil.
- Participation in another study that may affect erectile function or vascular measurements.
- Refusal or inability to provide informed consent.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Tadalafil 5 mg once daily
Adult men with predominantly vasculogenic erectile dysfunction who are eligible for tadalafil 5 mg once daily and enrolled in this prospective cohort study.
|
All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
其他名称：
|
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 |
|---|---|---|
|
Clinical response to tadalafil at 12 weeks
大体时间：12 weeks
|
Proportion of participants achieving clinical response, defined as an increase of at least 4 points in the IIEF-EF domain score from baseline together with a positive response to the Global Assessment Question.
The IIEF-EF domain scores erectile function on a higher-is-better scale; higher scores indicate better erectile function.
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the International Index of Erectile Function erectile function score.
大体时间：Baseline to 12 weeks
|
Change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF).
The IIEF-EF domain is a validated erectile function score, with higher values indicating better erectile function.
|
Baseline to 12 weeks
|
|
Change in Erection Hardness Score
大体时间：Baseline and12 weeks.
|
Change from baseline in the Erection Hardness Score, a 4-point scale used to assess penile rigidity during erection.
Higher scores indicate firmer erections.
|
Baseline and12 weeks.
|
|
Brachial artery flow-mediated dilatation
大体时间：Baseline
|
Association between baseline brachial artery flow-mediated dilatation percentage and clinical response to tadalafil.
Flow-mediated dilatation is a functional ultrasound-based measure of endothelial-dependent vasodilation; lower values indicate worse endothelial function.
Baseline FMD will be evaluated as an independent predictor of treatment response.
|
Baseline
|
|
Carotid intima-media thickness
大体时间：Baseline
|
Association between baseline mean carotid intima-media thickness and clinical response to tadalafil.
Carotid intima-media thickness is a structural ultrasound marker of subclinical atherosclerosis; higher values indicate more advanced vascular wall thickening.
Baseline CIMT will be evaluated as an independent predictor of treatment response.
|
Baseline
|
|
Serum endothelin-1 level
大体时间：Baseline
|
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
|
Baseline
|
|
Serum nitrite/nitrate level
大体时间：Baseline
|
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
|
Baseline
|
|
Serum high-sensitivity C-reactive protein
大体时间：Baseline
|
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
|
Baseline
|
|
Adverse events during tadalafil treatment
大体时间：Throughout the 12-week treatment period.
|
Number and type of treatment-emergent adverse events occurring during 12 weeks of tadalafil 5 mg once-daily therapy.
|
Throughout the 12-week treatment period.
|
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。
调查人员
- 首席研究员：Abul-fotouh Ahmed、Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
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 (实际的)
2026年8月19日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年8月16日
首先提交符合 QC 标准的
2026年8月16日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年8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.