Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

NCT06301854 | Completed Phase 3

• 1 other identifier: TPN171H-E302
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 34

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation.

  Adverse events occurring throughout the study period were assessed and graded.

  during the treatment and observation.

Secondary Outcomes (12)

• Change From Baseline in the International Index of Erectile Function - Erectile Function.

  baseline，3 months, 6 months

• Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses.

  baseline，3 months, 6 months

• Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses.

  baseline，3 months, 6 months

• Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication.

  baseline，3 months, 6 months

• Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction.

  baseline，3 months, 6 months

Study Arms (1)

TPN171H group

EXPERIMENTAL

10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.

Drug: TPN171H

Interventions

TPN171H DRUG

10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.

Also known as: Simmerafil

TPN171H group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100032, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510700, China

Location

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Shantou Central Hospital

Shantou, Guangdong, China

Location

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

Shenzhen Songgang People's Hospital

Shenzhen, Guangdong, 518105, China

Location

The 2nd Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

Qingyuan People's Hospital

Qingyuan, G, China

Location

The Second Hospital of Hebei Medical Uniyersity

Shijiazhuang, Hebei, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450100, China

Location

The First Affiliated Hospital of Henan University

Zhengzhou, Henan, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, 430014, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Changsha, Hunan, China

Location

Loudi Central Hospital

Loudi, Hunan, China

Location

Yueyang People's Hospital

Yueyang, Hunan, China

Location

Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215000, China

Location

Nanchang reproductive hospital

Nanchang, Jiangxi, 330001, China

Location

Yichang Central People's Hospital (Xiling Campus)

Yichang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Chifeng Municipal Hospital

Chifeng, Neimenggu, China

Location

The Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Location

Xianyang Central Hospital

Xianyang, Shanxi, China

Location

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xian, Shanxi, China

Location

Nuclear Industry 416 Hospital

Chengdu, Sichuang, China

Location

The Affiliated Hospital of Chengdu University

Chengdu, Sichuang, China

Location

Suining Central Hospital

Suining, Sichuang, China

Location

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hui Jiang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: April 12, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (34)