Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction
2026년 7월 7일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
780
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing, 중국
- Peking University Third Hospital
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Beijing, 중국
- Peking Union Medical College Hospital
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Beijing, 중국
- Peking University People's Hospital
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Beijing, 중국
- Peking University Shougang Hospital
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Beijing, 중국
- Beijing Tiantan Hospital
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Beijing, 중국
- Beijing Tsinghua Changgung Hospital
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Beijing, 중국
- Beijing Chaoyang Hospital Capital Medical University
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Beijing, 중국
- Xiyuan Hospital Beijing
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Changchun, 중국
- The First Hospital of Jilin University
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Changchun, 중국
- Affiliated Hospital of Changchun University of Chinese Medicine
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Changsha, 중국
- The Third XIANGYA Hospital of Central South University
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Chengdu, 중국
- Chengdu University Affiliated Hospital
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Dalian, 중국
- The First Affiliated Hospital of Dalian Medical University
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Fuzhou, 중국
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, 중국
- Guangzhou First People's Hospital
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Guangzhou, 중국
- The Fifth Affiliated Hospital of Guangzhou Medical University
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Guangzhou, 중국
- Nanfang Hospital Southern Medical University
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Guangzhou, 중국
- Guangdong Provincial Hospital of Chinese Medicine
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Hangzhou, 중국
- Zhejiang Provincial People's Hospital
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Hefei, 중국
- The First Affiliated Hospital of Anhui Medical University
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Hefei, 중국
- The Second Affiliated Hospital of Anhui Medical University
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Hefei, 중국
- Hefei Second People's Hospital
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Huai'an, 중국
- Huaian First People's Hospital
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Jinan, 중국
- Shandong Provincial Hospital
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Lanzhou, 중국
- The First Hospital of Lanzhou University
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Lanzhou, 중국
- Lanzhou University Second Hospital
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Nanchang, 중국
- The First Affiliated Hospital of Nanchang University
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Nanchang, 중국
- Jiangxi Provincial People's Hospital
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Nanchang, 중국
- Nanchang Reproductive Hospital
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Nanjing, 중국
- Nanjing Drum Tower Hospital
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Nanjing, 중국
- Jiangsu Province Hospital of Chinese Medicine
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Nanjing, 중국
- Nanjing Jiangning Hospital
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Nanning, 중국
- Nanning Second People's Hospital
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Shanghai, 중국
- Shanghai Pudong Hospital
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Shanghai, 중국
- Shanghai Tongji Hospital
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Shanghai, 중국
- Longhua Hospital Shanghai
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Shanghai, 중국
- Xinhua Hospital Shanghai
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Shenzhen, 중국
- The Eighth Affiliated Hospital of Sun Yat-sen University
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Shenzhen, 중국
- Shenzhen Bao'an Songgang People's Hospital
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Shijiazhuang, 중국
- The Second Hospital of Hebei Medical University
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Suzhou, 중국
- The First Affiliated Hospital of Soochow University
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Suzhou, 중국
- Nuclear Industry General Hospital
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Taiyuan, 중국
- First Hospital of Shanxi Medical University
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Tianjin, 중국
- Tianjin Medical University General Hospital
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Wenzhou, 중국
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, 중국
- Tongji Hospital Wuhan
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Wuhu, 중국
- Yijishan Hospital of Wannan Medical College
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Xi'an, 중국
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xiamen, 중국
- The First Affiliated Hospital of Xiamen University
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Xuzhou, 중국
- The Affiliated Hospital of Xuzhou Medical University
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Zhengzhou, 중국
- Henan Provincial People's Hospital
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Zhengzhou, 중국
- Zhengzhou People's Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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위약 비교기: 위약 그룹
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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.
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실험적: Tunodafil Hydrochloride Tablets 50mg group
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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.
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실험적: Tunodafil Hydrochloride Tablets 100mg group
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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12주차에 환자의 성적 접촉 프로필(SEP) 일지 질문 2의 기준선에서 예 응답 비율로 변경
기간: 기준선 및 12주
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SEP 다이어리 질문 2에 대한 예 응답 비율의 기준선에서 평균 변화를 평가했습니다. "섹스를 시도할 때 파트너의 질에 페니스를 삽입할 수 있었습니까?"
데이터는 참가자당 예 응답의 평균 백분율로 표시됩니다.
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기준선 및 12주
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12주차에 환자의 성적 접촉 프로필(SEP) 일지의 질문 3의 기준선에서 예 응답 비율로 변경
기간: 기준선 및 12주
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SEP 다이어리 질문 3에 대한 예 응답 비율의 기준선에서 평균 변화를 평가했습니다. "성공적인 성교를 할 수 있을 만큼 발기가 충분히 오래 지속되었습니까?"
데이터는 참가자당 예 응답의 평균 백분율로 표시됩니다.
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기준선 및 12주
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Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
기간: baseline and 12 weeks
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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
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baseline and 12 weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12
기간: baseline and 12 weeks
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Assessed was the changes in the number of subjects whose IIEF domain score at the 12th week visit was ≥26.
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baseline and 12 weeks
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Change From Baseline in the International Index of Erectile Function - Orgasmic Functions Domain (IIEF-OF) at Week 12
기간: baseline and 12 weeks
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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.
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baseline and 12 weeks
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Change From Baseline in the International Index of Erectile Function - Sexual Desire Domain (IIEF-SD) at Week 12
기간: baseline and 12 weeks
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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.
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baseline and 12 weeks
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Change From Baseline in the International Index of Erectile Function - Intercourse Satisfaction Domain (IIEF-IS) at Week 12
기간: baseline and 12 weeks
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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.
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baseline and 12 weeks
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Change From Baseline in the International Index of Erectile Function - Overall Satisfaction Domain (IIEF-OS) at Week 12
기간: baseline and 12 weeks
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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.
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baseline and 12 weeks
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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?
기간: 12 weeks
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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.
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12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
연구 시작
2021년 4월 1일
기본 완료 (실제)
기본 완료
2021년 11월 23일
연구 완료 (실제)
연구 완료
2022년 1월 25일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 24일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- YZJ200083-III-2028
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. .