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Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction

7 de julio de 2026 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

780

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Grupo placebo
Droga: 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
Droga: 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
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en la pregunta 2 del diario del perfil de encuentro sexual del paciente (SEP) en la semana 12 en porcentaje de respuestas afirmativas
Periodo de tiempo: línea de base y 12 semanas
Se evaluó el cambio medio desde el inicio en el porcentaje de respuestas afirmativas a la pregunta 2 del diario SEP. "¿Pudo insertar su pene en la vagina de su pareja cuando intentaba tener relaciones sexuales?" Los datos se presentan como el porcentaje medio de respuestas afirmativas por participante.
línea de base y 12 semanas
Cambio desde el inicio en la pregunta 3 del diario del perfil de encuentro sexual del paciente (SEP) en la semana 12 en porcentaje de respuestas afirmativas
Periodo de tiempo: línea de base y 12 semanas
Se evaluó el cambio medio desde el inicio en el porcentaje de respuestas afirmativas a la pregunta 3 del diario SEP. "¿Su erección duró lo suficiente como para tener relaciones sexuales exitosas?" Los datos se presentan como el porcentaje medio de respuestas afirmativas por participante.
línea de base y 12 semanas
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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?
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Yangtze River Pharmaceutical Group Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2021

Finalización primaria (Actual)

23 de noviembre de 2021

Finalización del estudio (Actual)

25 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2026

Publicado por primera vez (Actual)

9 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • YZJ200083-III-2028

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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