Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

Vigonvita Life Sciences

Status and phase

Completed

Phase 3

Conditions

Erectile Dysfunction

Treatments

Drug: TPN171H

Study type

Interventional

Funder types

Industry

Identifiers

NCT06301854

TPN171H-E302

Details and patient eligibility

About

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

Enrollment

472 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.