Long-term Safety of TPN171H Tablet in Erectile Dysfunction.
This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction.
- EligibilityCriteria: 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）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 7 drug half-times 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. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult