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Erectile DysfunctionPhase 3NCT07692867

Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction

A Phase 3 study testing Tunodafil Hydrochloride Tablets 50mg and Tunodafil Hydrochloride Tablets 100mg in people with Erectile Dysfunction, run by Yangtze River Pharmaceutical Group Co., Ltd. at 52 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Tunodafil Hydrochloride Tablets 50mg and Tunodafil Hydrochloride Tablets 100mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
780 participants
Where
52 sitesChina
Study dates
1 Apr 2021to 25 Jan 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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.
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  • 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.

Who cannot join

  • - 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.
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  • 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.

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

China52 sites

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing

  • Beijing Tiantan Hospital

    Beijing

  • Beijing Tsinghua Changgung Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Peking University Shougang Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Xiyuan Hospital Beijing

    Beijing

  • Affiliated Hospital of Changchun University of Chinese Medicine

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • The Third Xiangya Hospital of Central South University

    Changsha

  • Chengdu University Affiliated Hospital

    Chengdu

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou

  • Guangzhou First People's Hospital

    Guangzhou

  • Nanfang Hospital Southern Medical University

    Guangzhou

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • Hefei Second People's Hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

  • Huaian First People's Hospital

    Huai'an

  • Shandong Provincial Hospital

    Jinan

  • Lanzhou University Second Hospital

    Lanzhou

  • The First Hospital of Lanzhou University

    Lanzhou

  • Jiangxi Provincial People's Hospital

    Nanchang

  • Nanchang Reproductive Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing

  • Nanjing Drum Tower Hospital

    Nanjing

  • Nanjing Jiangning Hospital

    Nanjing

  • Nanning Second People's Hospital

    Nanning

  • Longhua Hospital Shanghai

    Shanghai

  • Shanghai Pudong Hospital

    Shanghai

  • Shanghai Tongji Hospital

    Shanghai

  • Xinhua Hospital Shanghai

    Shanghai

  • Shenzhen Bao'an Songgang People's Hospital

    Shenzhen

  • The Eighth Affiliated Hospital of Sun Yat-sen University

    Shenzhen

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

  • Nuclear Industry General Hospital

    Suzhou

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • First Hospital of Shanxi Medical University

    Taiyuan

  • Tianjin Medical University General Hospital

    Tianjin

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • Tongji Hospital Wuhan

    Wuhan

  • Yijishan Hospital of Wannan Medical College

    Wuhu

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Henan Provincial People's Hospital

    Zhengzhou

  • Zhengzhou People's Hospital

    Zhengzhou

Other trials in China

About this study

Official title: 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.

Being tested
Tunodafil Hydrochloride Tablets 50mg, Placebo, Tunodafil Hydrochloride Tablets 100mg
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tunodafil Hydrochloride Tablets 50mgDrug

    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.

  • PlaceboDrug

    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.

  • Tunodafil Hydrochloride Tablets 100mgDrug

    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.

Study groups in NCT07692867
Study groupRoleWhat they receive
Tunodafil Hydrochloride Tablets 50mg groupExperimentalNot described
Receives: Drug: Tunodafil Hydrochloride Tablets 50mg
Tunodafil Hydrochloride Tablets 100mg groupExperimentalNot described
Receives: Drug: Tunodafil Hydrochloride Tablets 100mg
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline and 12 weeks

  2. 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.

    Measured: baseline and 12 weeks

  3. 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.

    Measured: baseline and 12 weeks

Secondary outcomes (6)

  1. Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 12

    Assessed was the changes in the number of subjects whose IIEF domain score at the 12th week visit was ≥26.

    Measured: baseline and 12 weeks

  2. Change From Baseline in the International Index of Erectile Function - Orgasmic Functions Domain (IIEF-OF) at Week 12

    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.

    Measured: baseline and 12 weeks

  3. Change From Baseline in the International Index of Erectile Function - Sexual Desire Domain (IIEF-SD) at Week 12

    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.

    Measured: baseline and 12 weeks

  4. Change From Baseline in the International Index of Erectile Function - Intercourse Satisfaction Domain (IIEF-IS) at Week 12

    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.

    Measured: baseline and 12 weeks

  5. Change From Baseline in the International Index of Erectile Function - Overall Satisfaction Domain (IIEF-OS) at Week 12

    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.

    Measured: baseline and 12 weeks

  6. 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?

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start1 Apr 2021
  3. Primary completion23 Nov 2021
  4. Study completion25 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692867
Sponsor's protocol ID
YZJ200083-III-2028
Status last verified
Jun 2026
First submitted
24 Jun 2026
Last updated
9 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tunodafil Hydrochloride Tablets 50mg and Tunodafil Hydrochloride Tablets 100mg in people with Erectile Dysfunction, run by Yangtze River Pharmaceutical Group Co., Ltd. at 52 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07692867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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