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

TPN171H-E302

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

2024-04-12

2025-04-30

2025-04-30

Recruiting

Early phase I

400

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2024-04-26