Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

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）Thesubject must make at least four attempts at sexual intercourse during the untreatedbaseline period. （2）At least 50% of attempts during this period must beunsuccessful,（unsuccess means at least one of the first three questions should beanswered "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 3months after the last dose;

• Patients who have voluntarily decided to participate in this study, and signed theinformed 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 radicalprostatectomy or other surgery;

• Patients who have a penile implant;

• Patients who do not respond to marketed PDE5 inhibitors or have adverse reactionsthat lead to drug discontinuation;

• CYP3A4 potent inhibitors, moderate inhibitors, and potent inducers need to be usedduring the trial or discontinued for less than 31 days before enrollment;

• Subjects who are taking nitrate or NO donor drugs, guanylate cyclase agonists andcannot be discontinued during the trial;

• Patients with the following cardiovascular disease: Myocardial infarction or strokewithin the last 6 months; Unstable angina or angina occurring during sexualintercourse; 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 degenerativeretinopathy, 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 peripheralmuscular neurological disease in the past 6 months;

• Patient with a history of malignancy;

• Patients with significant neurological abnormalities who are unable or unwilling tocooperate;

• Patients whose partner is breastfeeding/pregnant/trying to become pregnant, has agynecological 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 isdeemed inappropriate.