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Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction

7 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

780

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Grupo placebo
Medicamento: 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.
Experimental: Tunodafil Hydrochloride Tablets 50mg group
Medicamento: 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.
Experimental: Tunodafil Hydrochloride Tablets 100mg group
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mudança da linha de base na pergunta 2 do diário do perfil de encontro sexual do paciente (SEP) na semana 12 na porcentagem de respostas sim
Prazo: linha de base e 12 semanas
Foi avaliada a alteração média desde a linha de base na porcentagem de respostas Sim à Pergunta 2 do diário SEP. "Você conseguiu inserir seu pênis na vagina de sua parceira quando estava tentando fazer sexo?" Os dados são apresentados como a porcentagem média de respostas sim por participante.
linha de base e 12 semanas
Mudança da linha de base na pergunta 3 do diário do perfil de encontro sexual do paciente (SEP) na semana 12 na porcentagem de respostas sim
Prazo: linha de base e 12 semanas
Avaliada foi a mudança média da linha de base na porcentagem de respostas Sim à Pergunta 3 do diário SEP. "Sua ereção durou o suficiente para você ter relações sexuais bem-sucedidas?" Os dados são apresentados como a porcentagem média de respostas sim por participante.
linha de base e 12 semanas
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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?
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Yangtze River Pharmaceutical Group Co., Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2021

Conclusão Primária (Real)

23 de novembro de 2021

Conclusão do estudo (Real)

25 de janeiro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de julho de 2026

Primeira postagem (Real)

9 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • YZJ200083-III-2028

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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