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

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: TPN171H

• Study Type: Interventional
• Enrollment (Actual): 472
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100032
      • Peking University First Hospital
  • G
    • Qingyuan, G, China
      • Qingyuan People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510700
      • The Fifth Affiliated Hospital of Guangzhou Medical University
    • Shantou, Guangdong, China
      • Shantou Central Hospital
    • Shantou, Guangdong, China
      • The Second Affiliated Hospital Of Shantou University Medical College
    • Shenzhen, Guangdong, China, 518105
      • Shenzhen Songgang People's Hospital
  • Guangxi
    • Guilin, Guangxi, China
      • The 2nd Affiliated Hospital of Guilin Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • The Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical Uniyersity
    • Xingtai, Hebei, China
      • Xingtai People's Hospital
  • Henan
    • Zhengzhou, Henan, China, 450100
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Henan University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
    • Wuhan, Hubei, China, 430014
      • The Central Hospital of Wuhan
  • Hunan
    • Changsha, Hunan, China
      • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
    • Loudi, Hunan, China
      • Loudi Central Hospital
    • Yueyang, Hunan, China
      • Yueyang People's Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Second Affiliated Hospital of Suzhou University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330001
      • Nanchang reproductive hospital
    • Yichang, Jiangxi, China
      • Yichang Central People's Hospital (Xiling Campus)
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The Second Hospital of Dalian Medical University
  • Neimenggu
    • Chifeng, Neimenggu, China
      • Chifeng Municipal Hospital
  • Qinghai
    • Xining, Qinghai, China
      • The Affiliated Hospital of Qinghai University
  • Shanxi
    • Xian, Shanxi, China
      • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
    • Xianyang, Shanxi, China
      • Xianyang Central Hospital
  • Sichuang
    • Chengdu, Sichuang, China
      • Nuclear Industry 416 Hospital
    • Chengdu, Sichuang, China
      • The Affiliated Hospital of Chengdu University
    • Suining, Sichuang, China
      • Suining Central Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPN171H group; 10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.	Drug: TPN171H; 10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.; Other Names: Simmerafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the International Index of Erectile Function - Erectile Function.	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 .	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.	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.	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.	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.	baseline，3 months, 6 months
Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication.	Assessed was the changes in the number of subjects whose IIEF domain score at the 6th month visit was ≥26.	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.	Self-reported, Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction.	baseline，3 months, 6 months
Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month.	Percentage of respondents who answered "yes" to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of "yes" answers per participant.	3 months, 6 months
Change From Baseline in the International Index of Erectile Function - Erectile Function.	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 .	baseline，3 months, 6 months, 9 months and 12 months
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month 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.	baseline，3 months, 6 months, 9 months and 12 months
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat 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.	baseline，3 months, 6 months, 9 months and 12 months
Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication.	Assessed was the changes in the number of subjects whose IIEF domain score at the 3rd，6th，9th，12th month visit was ≥26.	baseline，3 months, 6 months, 9 months and 12 months
Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction.	Self-reported, Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction.	baseline, 3 months, 6 months, 9 months and 12 months
Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month .	Percentage of respondents who answered "yes" to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of "yes" answers per participant.	3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Hui Jiang, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: TPN171H-E302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No