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