Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill could help men with erectile dysfunction achieve and maintain erections

NCT ID NCT07692867

Disease control Sponsor: Yangtze River Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This clinical trial tests an investigational drug called tunodafil hydrochloride, taken as a tablet about one hour before sexual activity. The study enrolls men aged 18 to 65 with erectile dysfunction who have a stable female partner. Over 12 weeks, researchers measure changes in erectile function and intercourse success compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tunodafil hydrochloride tablets
What this could lead to
If successful, this could provide a new oral treatment option for men with erectile dysfunction, improving erection hardness and intercourse success.
What could go wrong
This is a Phase 3 trial, but results may not confirm superiority over existing treatments. Side effects typical of this drug class (e.g., headache, flushing) are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

780 people

The number who actually took part.

Started

Apr 2021

Finished

Jan 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Erectile dysfunction are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

erectile dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erectile dysfunction

Contacts and locations

Locations

  • Affiliated Hospital of Changchun University of Chinese Medicine

    Changchun, China

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, China

  • Beijing Tiantan Hospital

    Beijing, China

  • Beijing Tsinghua Changgung Hospital

    Beijing, China

  • Chengdu University Affiliated Hospital

    Chengdu, China

  • First Hospital of Shanxi Medical University

    Taiyuan, China

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, China

  • Guangzhou First People's Hospital

    Guangzhou, China

  • Hefei Second People's Hospital

    Hefei, China

  • Henan Provincial People's Hospital

    Zhengzhou, China

  • Huaian First People's Hospital

    Huai'an, China

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, China

  • Jiangxi Provincial People's Hospital

    Nanchang, China

  • Lanzhou University Second Hospital

    Lanzhou, China

  • Longhua Hospital Shanghai

    Shanghai, China

  • Nanchang Reproductive Hospital

    Nanchang, China

  • Nanfang Hospital Southern Medical University

    Guangzhou, China

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • Nanjing Jiangning Hospital

    Nanjing, China

  • Nanning Second People's Hospital

    Nanning, China

  • Nuclear Industry General Hospital

    Suzhou, 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

  • Shandong Provincial Hospital

    Jinan, China

  • Shanghai Pudong Hospital

    Shanghai, China

  • Shanghai Tongji Hospital

    Shanghai, China

  • Shenzhen Bao'an Songgang People's Hospital

    Shenzhen, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, China

  • The Eighth Affiliated Hospital of Sun Yat-sen University

    Shenzhen, China

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, China

  • The First Hospital of Jilin University

    Changchun, China

  • The First Hospital of Lanzhou University

    Lanzhou, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, China

  • The Third Xiangya Hospital of Central South University

    Changsha, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Tongji Hospital Wuhan

    Wuhan, China

  • Xinhua Hospital Shanghai

    Shanghai, China

  • Xiyuan Hospital Beijing

    Beijing, China

  • Yijishan Hospital of Wannan Medical College

    Wuhu, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

  • Zhengzhou People's Hospital

    Zhengzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.