long-term safety of tpn171h tablet in erectile dysfunction.

Conditions: Erectile Dysfunction

Summary: this is a multicenter, open study to evaluate the long-term safety and efficacy of tpn171h in men with erectile dysfunction.


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.