Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Tunodafil Hydrochloride Tablets in Patients With Erectile Dysfunction
1 other identifier
interventional
780
1 country
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Shorter than P25 for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedFirst Submitted
Initial submission to the registry
June 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedJuly 9, 2026
June 1, 2026
8 months
June 24, 2026
July 7, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
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
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina when you are trying to have sex ?" Data are presented as the mean percentage of yes responses per participant.
baseline and 12 weeks
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.
baseline and 12 weeks
Secondary Outcomes (6)
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Orgasmic Functions Domain (IIEF-OF) at Week 12
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Sexual Desire Domain (IIEF-SD) at Week 12
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Intercourse Satisfaction Domain (IIEF-IS) at Week 12
baseline and 12 weeks
Change From Baseline in the International Index of Erectile Function - Overall Satisfaction Domain (IIEF-OS) at Week 12
baseline and 12 weeks
- +1 more secondary outcomes
Study Arms (3)
Tunodafil Hydrochloride Tablets 50mg group
EXPERIMENTALTunodafil Hydrochloride Tablets 100mg group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- \- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Beijing Chaoyang Hospital Capital Medical University
Beijing, China
Beijing Tiantan Hospital
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Peking University Shougang Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Xiyuan Hospital Beijing
Beijing, China
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, China
The First Hospital of Jilin University
Changchun, China
The Third Xiangya Hospital of Central South University
Changsha, China
Chengdu University Affiliated Hospital
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, China
Guangzhou First People's Hospital
Guangzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Hefei Second 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
Huaian First People's Hospital
Huai'an, China
Shandong Provincial Hospital
Jinan, China
Lanzhou University Second Hospital
Lanzhou, China
The First Hospital of Lanzhou University
Lanzhou, China
Jiangxi Provincial People's Hospital
Nanchang, China
Nanchang Reproductive Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
Nanjing Jiangning Hospital
Nanjing, China
Nanning Second People's Hospital
Nanning, China
Longhua Hospital Shanghai
Shanghai, China
Shanghai Pudong Hospital
Shanghai, China
Shanghai Tongji Hospital
Shanghai, China
Xinhua Hospital Shanghai
Shanghai, China
Shenzhen Bao'an Songgang People's Hospital
Shenzhen, China
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Nuclear Industry General Hospital
Suzhou, China
The First Affiliated Hospital of Soochow University
Suzhou, China
First Hospital of Shanxi Medical University
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Tongji Hospital Wuhan
Wuhan, China
Yijishan Hospital of Wannan Medical College
Wuhu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Zhengzhou People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
July 9, 2026
Study Start
April 1, 2021
Primary Completion
November 23, 2021
Study Completion
January 25, 2022
Last Updated
July 9, 2026
Record last verified: 2026-06