Long-term Safety of TPN171H Tablet in Erectile Dysfunction.
NCT ID: NCT06301854
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
472 participants
INTERVENTIONAL
2024-04-12
2025-06-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.
NCT05188989
Pharmacodynamic Study of TPN171H Tablets in Patients With Mild to Moderate Erectile Dysfunction
NCT05388825
Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects
NCT06090136
Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction
NCT04479917
Effect of TPN171H on Spermatogenesis
NCT05585931
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TPN171H group
10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.
TPN171H
10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TPN171H
10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Males with ED at least 3 months;
* IIEF-5 ≤ 21 at visit 1;
* Patients in a stable, heterosexual relationship during the study;
* At the end of the untreated baseline period, the following conditions are met：（1）The subject must make at least four attempts at sexual intercourse during the untreated baseline period. （2）At least 50% of attempts during this period must be unsuccessful,（unsuccess means at least one of the first three questions should be answered "No" in SEP）.（3）5≤IIEF-EF≤25.
* Patients who are willing to have 4 or more attempts of sexual intercourse per month, demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
* Patients who are willing to take proper contraceptive during the study and within 3 months after the last dose;
* Patients who have voluntarily decided to participate in this study, and signed the informed consent form.
Exclusion Criteria
* Patients with anatomical malformations of the penis;
* Patients with primary hypoactive sexual desire;
* Patients with ED, which is caused by any other primary sexual disorder;
* Patients with ED, which is caused by spinal injury or have had a radical prostatectomy or other surgery;
* Patients who have a penile implant;
* Patients who do not respond to marketed PDE5 inhibitors or have adverse reactions that lead to drug discontinuation;
* CYP3A4 potent inhibitors, moderate inhibitors, and potent inducers need to be used during the trial or discontinued for less than 31 days before enrollment;
* Subjects who are taking nitrate or NO donor drugs, guanylate cyclase agonists and cannot be discontinued during the trial;
* Patients with the following cardiovascular disease: Myocardial infarction or stroke within the last 6 months; Unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months;
* Uncontrolled hypotension (\<90/60mmHg) or uncontrolled hypertension (≥180/110mmHg);
* Patients with diabetic complications (diabetic nephropathy, peripheral neuropathy);
* Patients with hepatic or renal dysfunction as per the following: AST, ALT\>3\*ULN, serum creatinine exceeds 50% of the upper limit of normal value;
* Patients with active gastrointestinal ulcers and bleeding disorders;
* Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosa;
* Patients who have a history of sudden decrease or loss of hearing;
* Patients with a history of severe central nervous system injury or peripheral muscular neurological disease in the past 6 months;
* Patient with a history of malignancy;
* Patients with significant neurological abnormalities who are unable or unwilling to cooperate;
* Patients whose partner is breastfeeding/pregnant/trying to become pregnant, has a gynecological disease or is restricted in their activities during treatment;
* Patients who have used other drugs in clinical trials within the last 1 month;
* For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate.
18 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vigonvita Life Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hui Jiang
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Shenzhen Songgang People's Hospital
Shenzhen, Guangdong, China
The 2nd Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Qingyuan People's Hospital
Qingyuan, G, China
The Second Hospital of Hebei Medical Uniyersity
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University
Zhengzhou, Henan, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Wuhan Union Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China
Loudi Central Hospital
Loudi, Hunan, China
Yueyang People's Hospital
Yueyang, Hunan, China
Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Nanchang reproductive hospital
Nanchang, Jiangxi, China
Yichang Central People's Hospital (Xiling Campus)
Yichang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, China
The Affiliated Hospital of Qinghai University
Xining, Qinghai, China
Xianyang Central Hospital
Xianyang, Shanxi, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xian, Shanxi, China
Nuclear Industry 416 Hospital
Chengdu, Sichuang, China
The Affiliated Hospital of Chengdu University
Chengdu, Sichuang, China
Suining Central Hospital
Suining, Sichuang, China
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Ürümqi, Xinjiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TPN171H-E302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.