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Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction

7. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

780

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo gruppe
Legemiddel: 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.
Eksperimentell: Tunodafil Hydrochloride Tablets 50mg group
Legemiddel: 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.
Eksperimentell: Tunodafil Hydrochloride Tablets 100mg group
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i spørsmål 2 i pasientens seksuelle møteprofil (SEP) dagbok ved uke 12 i prosent av ja-svar
Tidsramme: baseline og 12 uker
Vurdert var den gjennomsnittlige endringen fra baseline i prosentandelen Ja-svar på SEP-dagboken Spørsmål 2. "Kunne du sette inn penisen din i partnerens vagina når du prøver å ha sex?" Data presenteres som gjennomsnittlig prosentandel av ja-svar per deltaker.
baseline og 12 uker
Endring fra baseline i spørsmål 3 i pasientens seksuelle møteprofil (SEP) dagbok ved uke 12 i prosent av ja-svar
Tidsramme: baseline og 12 uker
Vurdert var den gjennomsnittlige endringen fra baseline i prosentandelen Ja-svar på SEP-dagboken Spørsmål 3. "Varte ereksjonen din lenge nok til at du kunne ha vellykket samleie?" Data presenteres som gjennomsnittlig prosentandel av ja-svar per deltaker.
baseline og 12 uker
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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?
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yangtze River Pharmaceutical Group Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2021

Primær fullføring (Faktiske)

23. november 2021

Studiet fullført (Faktiske)

25. januar 2022

Datoer for studieregistrering

Først innsendt

24. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YZJ200083-III-2028

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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