Evaluating the long-term safety of TPN171H tablet for erectile dysfunction

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

This study is testing whether the TPN171H tablet is safe and effective for men aged 18 to 75 who have been dealing with erectile dysfunction for at least three months.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: Vigonvita Life Sciences (Industry-sponsored)
• Locations: 34 sites (Hefei, Anhui and 33 other locations)
• Trial ID: NCT06301854 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to assess the long-term safety and efficacy of the TPN171H tablet in men suffering from erectile dysfunction (ED). Participants will be men aged 18 to 75 who have experienced ED for at least three months and meet specific criteria regarding their sexual performance. The study will monitor the participants' responses to the treatment over an extended period to determine its effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates for this study are males aged 18 to 75 who have been diagnosed with erectile dysfunction for at least three months.

Not a fit: Patients who do not have erectile dysfunction or those who are not in a stable heterosexual relationship may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve sexual function and quality of life for men with erectile dysfunction.

How similar studies have performed: Other studies evaluating treatments for erectile dysfunction have shown promising results, indicating that this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 33 other locations

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

Study contacts

• Principal investigator: Hui Jiang — Peking University First Hospital
• Study coordinator: Huaqing Duan

Conditions Erectile Dysfunction