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Endothelial Markers and Tadalafil Response

2026년 8월 19일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

120

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 이집트
      • Cairo, 이집트
        • 모병
        • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
의약품: Tadalafil 5mg
All enrolled participants will receive tadalafil 5 mg orally once daily for 12 weeks as part of clinical management.
다른 이름들:
  • PDE5 억제제

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical response to tadalafil at 12 weeks
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in the International Index of Erectile Function erectile function score.
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Serum nitrite/nitrate level
기간: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Serum high-sensitivity C-reactive protein
기간: Baseline
Baseline biomarker levels will be evaluated as independent predictors of treatment response.
Baseline
Adverse events during tadalafil treatment
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Al-Azhar University

수사관

  • 수석 연구원: Abul-fotouh Ahmed, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 19일

기본 완료 (추정된)

2028년 8월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 8월 16일

QC 기준을 충족하는 최초 제출

2026년 8월 16일

처음 게시됨 (실제)

2026년 8월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 19일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • UroAzhar_18_026

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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