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Long-term Safety of TPN171H Tablet in Erectile Dysfunction. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

A Multicenter, Open Study to Evaluate the Long-term Safety and Efficacy of TPN171H in Patients With Erectile Dysfunction

NCT06301854•Vigonvita Life Sciences

View on ClinicalTrials.gov

Summary

This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction.

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•18 years to 75 years (inclusive);
•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 who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H;
•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;
+12 more criteria

Locations (34)

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

Key Dates

Start Date

April 12, 2024

Primary Completion Date

June 5, 2025

Completion Date

June 5, 2025

Last Updated

July 25, 2025

Enrollment

472

ACTUAL participants

Conditions

Erectile Dysfunction

Interventions

TPN171H

DRUG

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Erectile Dysfunction With Diabetes Mellitus

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RECRUITINGPHASE2

TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

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Erectile Dysfunction Due to Arterial DiseaseAtheroscleroses+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

Inclusion Criteria

Exclusion Criteria

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