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Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction

2026年7月7日 更新者：Yangtze River Pharmaceutical Group Co., Ltd.

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Tunodafil Hydrochloride Tablets in Patients With Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of Tunodafil Hydrochloride Tablets in men with erectile dysfunction.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

780

阶段

  • 第三阶段

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

  • 中国
      • Beijing、中国
        • Peking University Third Hospital
      • Beijing、中国
        • Peking Union Medical College Hospital
      • Beijing、中国
        • Peking University People's Hospital
      • Beijing、中国
        • Peking University Shougang Hospital
      • Beijing、中国
        • Beijing Tiantan Hospital
      • Beijing、中国
        • Beijing Tsinghua Changgung Hospital
      • Beijing、中国
        • Beijing Chaoyang Hospital Capital Medical University
      • Beijing、中国
        • Xiyuan Hospital Beijing
      • Changchun、中国
        • The First Hospital of Jilin University
      • Changchun、中国
        • Affiliated Hospital of Changchun University of Chinese Medicine
      • Changsha、中国
        • The Third XIANGYA Hospital of Central South University
      • Chengdu、中国
        • Chengdu University Affiliated Hospital
      • Dalian、中国
        • The First Affiliated Hospital of Dalian Medical University
      • Fuzhou、中国
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou、中国
        • Guangzhou First People's Hospital
      • Guangzhou、中国
        • The Fifth Affiliated Hospital of Guangzhou Medical University
      • Guangzhou、中国
        • Nanfang Hospital Southern Medical University
      • Guangzhou、中国
        • Guangdong Provincial Hospital of Chinese Medicine
      • Hangzhou、中国
        • Zhejiang Provincial People's Hospital
      • Hefei、中国
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei、中国
        • The Second Affiliated Hospital of Anhui Medical University
      • Hefei、中国
        • Hefei Second People's Hospital
      • Huai'an、中国
        • Huaian First People's Hospital
      • Jinan、中国
        • Shandong Provincial Hospital
      • Lanzhou、中国
        • The First Hospital of Lanzhou University
      • Lanzhou、中国
        • Lanzhou University Second Hospital
      • Nanchang、中国
        • The First Affiliated Hospital of Nanchang University
      • Nanchang、中国
        • Jiangxi Provincial People's Hospital
      • Nanchang、中国
        • Nanchang Reproductive Hospital
      • Nanjing、中国
        • Nanjing Drum Tower Hospital
      • Nanjing、中国
        • Jiangsu Province Hospital of Chinese Medicine
      • Nanjing、中国
        • Nanjing Jiangning Hospital
      • Nanning、中国
        • Nanning Second People's Hospital
      • Shanghai、中国
        • Shanghai Pudong Hospital
      • Shanghai、中国
        • Shanghai Tongji Hospital
      • Shanghai、中国
        • Longhua Hospital Shanghai
      • Shanghai、中国
        • Xinhua Hospital Shanghai
      • Shenzhen、中国
        • The Eighth Affiliated Hospital of Sun Yat-sen University
      • Shenzhen、中国
        • Shenzhen Bao'an Songgang People's Hospital
      • Shijiazhuang、中国
        • The Second Hospital of Hebei Medical University
      • Suzhou、中国
        • The First Affiliated Hospital of Soochow University
      • Suzhou、中国
        • Nuclear Industry General Hospital
      • Taiyuan、中国
        • First Hospital of Shanxi Medical University
      • Tianjin、中国
        • Tianjin Medical University General Hospital
      • Wenzhou、中国
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan、中国
        • Tongji Hospital Wuhan
      • Wuhu、中国
        • Yijishan Hospital of Wannan Medical College
      • Xi'an、中国
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xiamen、中国
        • The First Affiliated Hospital of Xiamen University
      • Xuzhou、中国
        • The Affiliated Hospital of Xuzhou Medical University
      • Zhengzhou、中国
        • Henan Provincial People's Hospital
      • Zhengzhou、中国
        • Zhengzhou People's Hospital

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:

  • - Male subjects aged between 18 and 65 years (inclusive) diagnosed with Erectile Dysfunction (ED).
  • At Visit 1, subjects must have an International Index of Erectile Function-5 (IIEF-5) score ≤ 21, with a disease duration of at least 6 months.
  • Subjects must have a stable marital relationship or a stable female sexual partner for at least 3 months prior to screening and throughout the study period.
  • Subjects must agree to attempt sexual intercourse at least 4 times per visit cycle.
  • Subjects agree not to use any other ED treatments during the study, including PDE5 inhibitors, traditional Chinese medicine (including decoctions and patent medicines), or medical devices for ED treatment.
  • Subjects (and their partners) must have no plans for conception from the time of screening up to 3 months after the last dose, and must voluntarily use effective contraceptive measures.
  • Subjects must voluntarily provide written informed consent.

  • Upon completion of the run-in period, subjects must meet all of the following three conditions:

    • At least 4 sexual intercourse attempts were made during the run-in period; ② The failure rate of sexual intercourse attempts was ≥ 50% (failure defined as at least one "No" answer to the first three questions of the Sexual Encounter Profile [SEP] diary); ③ The IIEF-Erectile Function (IIEF-EF) domain score was ≥ 5 and ≤ 25.

Exclusion Criteria:

  • - Subjects with obvious congenital malformations or anatomical abnormalities of the genitalia that significantly impair penile erection.
  • Subjects with erectile dysfunction caused by other sexual dysfunction disorders (e.g., ejaculatory disorders) or uncontrolled endocrine diseases despite medication (e.g., hypogonadism, hyperthyroidism/hypothyroidism, pituitary tumors).
  • Subjects with erectile dysfunction resulting from spinal cord injury or radical prostatectomy.
  • Subjects with a history of penile prosthesis implantation.
  • Subjects with a history of sudden hearing loss or deafness.
  • Subjects who have previously failed PDE5 inhibitor therapy for erectile dysfunction.

  • Subjects with any history of the following cardiac conditions:

    • Myocardial infarction or stroke within the past 6 months;
    • Concomitant unstable angina or angina occurring during sexual intercourse;
    • New York Heart Association (NYHA) Class ≥ II heart failure within the past 6 months;
    • Concomitant uncontrolled hypertension (≥160/95 mmHg), hypotension (<90/60 mmHg), or orthostatic hypotension.
  • Subjects currently using, or unable to discontinue during the study, any formulation of nitrates or nitric oxide (NO) donors, α1-adrenergic receptor blockers (e.g., doxazosin, prazosin), strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), or guanylate cyclase stimulators (e.g., riociguat).
  • Subjects with a history of anti-androgen therapy, or androgen replacement therapy initiated less than 3 months prior to screening without a stable maintenance regimen.
  • Subjects with poorly controlled diabetes mellitus, defined as fasting blood glucose >1.5 times the upper limit of normal (ULN), or those with diabetic complications (diabetic nephropathy, peripheral neuropathy).
  • Subjects with severe hepatic or renal impairment, defined as AST and/or ALT >2 × ULN; or creatinine clearance (CrCl) <30.0 mL/min.
  • Subjects with a history of severe chronic or acute hepatitis.
  • Subjects who have used vacuum constriction devices (VCD), intracavernosal injections (ICI), or other ED therapies and are unable to discontinue these treatments during the study.
  • Subjects with known color vision abnormalities, retinitis pigmentosa, macular degeneration, non-arteritic anterior ischemic optic neuropathy (NAION), or other fundus disease histories.
  • Subjects with severe central nervous system damage within the past 6 months (cerebrovascular diseases such as cerebral hemorrhage or ischemia, inflammatory brain diseases such as encephalitis or meningitis, craniocerebral trauma, or spinal cord injury), or peripheral nervous system injury or lesions.
  • Subjects with a history of high-risk arrhythmias, or ECG-confirmed arrhythmias, or those with clinically significant abnormal ECG findings at screening as judged by the Investigator.
  • Subjects with a history of malignant tumors within the past 3 years (excluding basal cell carcinoma, squamous cell carcinoma of the skin, or other non-invasive lesions deemed cured by the Investigator with minimal recurrence risk).
  • Subjects with a known hypersensitivity to the investigational product or drugs of the same class.
  • Subjects with a history of psychiatric disorders.
  • Subjects with a history of substance abuse, drug addiction, or alcoholism (characterized by impaired tolerance, withdrawal, or control over drinking behavior) within the past year.
  • Subjects who participated in another clinical trial within 1 month prior to screening.
  • Subjects whose female partners are <18 years of age, or whose partners are known to be pregnant at screening, unwilling to use appropriate contraception during the study, or are breastfeeding.
  • Subjects whose partners have gynecological conditions that may affect sexual activity or other medical conditions limiting their participation in the clinical trial.
  • Subjects deemed unsuitable for inclusion by the Investigator for any other reason.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂组
药品：Placebo
All enrolled participants will receive a 12-week treatment regimen. Researchers shall instruct participants on proper medication administration, requiring the drug to be taken approximately 1 hour prior to sexual activity and followed by sexual stimulation. Each participant must take the medication at least four times per visit cycle, with no more than one dose administered within a 24-hour period.
实验性的：Tunodafil Hydrochloride Tablets 50mg group
药品：Tunodafil Hydrochloride Tablets 50mg
All enrolled participants will receive a 12-week treatment regimen. Researchers shall instruct participants on proper medication administration, requiring the drug to be taken approximately 1 hour prior to sexual activity and followed by sexual stimulation. Each participant must take the medication at least four times per visit cycle, with no more than one dose administered within a 24-hour period.
实验性的：Tunodafil Hydrochloride Tablets 100mg group
药品：Tunodafil Hydrochloride Tablets 100mg
All enrolled participants will receive a 12-week treatment regimen. Researchers shall instruct participants on proper medication administration, requiring the drug to be taken approximately 1 hour prior to sexual activity and followed by sexual stimulation. Each participant must take the medication at least four times per visit cycle, with no more than one dose administered within a 24-hour period.

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
第 12 周患者性接触档案 (SEP) 日记中问题 2 中“是”回答百分比的基线变化
大体时间：基线和 12 周
评估的是对 SEP 日记问题 2 的“是”回答的百分比相对于基线的平均变化。 数据以每个参与者的“是”响应的平均百分比表示。
基线和 12 周
第 12 周患者性接触档案 (SEP) 日记中问题 3 中“是”回答百分比的基线变化
大体时间：基线和 12 周
评估的是对 SEP 日记问题 3 的“是”回答的百分比相对于基线的平均变化。 数据以每个参与者的“是”响应的平均百分比表示。
基线和 12 周
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
大体时间：baseline and 12 weeks
The primary efficacy variable was the change in the EF domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 1-5 and 15 from the IIEF questionnaire
baseline and 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12
大体时间：baseline and 12 weeks
Assessed was the changes in the number of subjects whose IIEF domain score at the 12th week visit was ≥26.
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Orgasmic Functions Domain (IIEF-OF) at Week 12
大体时间：baseline and 12 weeks
The change in the OF domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 9 and 10 from the IIEF questionnaire.
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Sexual Desire Domain (IIEF-SD) at Week 12
大体时间：baseline and 12 weeks
The change in the SD domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 11 and 12 from the IIEF questionnaire.
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Intercourse Satisfaction Domain (IIEF-IS) at Week 12
大体时间：baseline and 12 weeks
The change in the IS domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 6-8 from the IIEF questionnaire.
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Overall Satisfaction Domain (IIEF-OS) at Week 12
大体时间：baseline and 12 weeks
The change in the OS domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 13 and 14 from the IIEF questionnaire.
baseline and 12 weeks
Proportion of patients answering "Yes" on the Global Assessment Questionnaire (GAQ). Over the past 4 weeks during treatment, has there been an improvement in erectile function following medication use?
大体时间：12 weeks
Proportion of patients answering "Yes" to the Global Assessment Questionnaire (GAQ) question ("Over the past 4 weeks during treatment, has there been an improvement in erectile function following medication use?") at Week 12.
12 weeks

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。

赞助

Yangtze River Pharmaceutical Group Co., Ltd.

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)

2021年4月1日

初级完成 (实际的)

2021年11月23日

研究完成 (实际的)

2022年1月25日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • YZJ200083-III-2028

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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