A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Tunodafil Hydrochloride Tablets in Patients With Erectile Dysfunction
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Tunodafil Hydrochloride Tablets in Patients With Erectile Dysfunction
This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of Tunodafil Hydrochloride Tablets in men with erectile dysfunction.
Inclusion Criteria:
- Male subjects aged between 18 and 65 years (inclusive) diagnosed with Erectile Dysfunction (ED).
At Visit 1, subjects must have an International Index of Erectile Function-5 (IIEF-5) score ≤ 21, with a disease duration of at least 6 months.
Subjects must have a stable marital relationship or a stable female sexual partner for at least 3 months prior to screening and throughout the study period.
Subjects must agree to attempt sexual intercourse at least 4 times per visit cycle.
Subjects agree not to use any other ED treatments during the study, including PDE5 inhibitors, traditional Chinese medicine (including decoctions and patent medicines), or medical devices for ED treatment.
Subjects (and their partners) must have no plans for conception from the time of screening up to 3 months after the last dose, and must voluntarily use effective contraceptive measures.
Subjects must voluntarily provide written informed consent.
Upon completion of the run-in period, subjects must meet all of the following three conditions:
Exclusion Criteria:
- Subjects with obvious congenital malformations or anatomical abnormalities of the genitalia that significantly impair penile erection.
Subjects with erectile dysfunction caused by other sexual dysfunction disorders (e.g., ejaculatory disorders) or uncontrolled endocrine diseases despite medication (e.g., hypogonadism, hyperthyroidism/hypothyroidism, pituitary tumors).
Subjects with erectile dysfunction resulting from spinal cord injury or radical prostatectomy.
Subjects with a history of penile prosthesis implantation.
Subjects with a history of sudden hearing loss or deafness.
Subjects who have previously failed PDE5 inhibitor therapy for erectile dysfunction.
Subjects with any history of the following cardiac conditions:
Subjects currently using, or unable to discontinue during the study, any formulation of nitrates or nitric oxide (NO) donors, α1-adrenergic receptor blockers (e.g., doxazosin, prazosin), strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), or guanylate cyclase stimulators (e.g., riociguat).
Subjects with a history of anti-androgen therapy, or androgen replacement therapy initiated less than 3 months prior to screening without a stable maintenance regimen.
Subjects with poorly controlled diabetes mellitus, defined as fasting blood glucose >1.5 times the upper limit of normal (ULN), or those with diabetic complications (diabetic nephropathy, peripheral neuropathy).
Subjects with severe hepatic or renal impairment, defined as AST and/or ALT >2 × ULN; or creatinine clearance (CrCl) <30.0 mL/min.
Subjects with a history of severe chronic or acute hepatitis.
Subjects who have used vacuum constriction devices (VCD), intracavernosal injections (ICI), or other ED therapies and are unable to discontinue these treatments during the study.
Subjects with known color vision abnormalities, retinitis pigmentosa, macular degeneration, non-arteritic anterior ischemic optic neuropathy (NAION), or other fundus disease histories.
Subjects with severe central nervous system damage within the past 6 months (cerebrovascular diseases such as cerebral hemorrhage or ischemia, inflammatory brain diseases such as encephalitis or meningitis, craniocerebral trauma, or spinal cord injury), or peripheral nervous system injury or lesions.
Subjects with a history of high-risk arrhythmias, or ECG-confirmed arrhythmias, or those with clinically significant abnormal ECG findings at screening as judged by the Investigator.
Subjects with a history of malignant tumors within the past 3 years (excluding basal cell carcinoma, squamous cell carcinoma of the skin, or other non-invasive lesions deemed cured by the Investigator with minimal recurrence risk).
Subjects with a known hypersensitivity to the investigational product or drugs of the same class.
Subjects with a history of psychiatric disorders.
Subjects with a history of substance abuse, drug addiction, or alcoholism (characterized by impaired tolerance, withdrawal, or control over drinking behavior) within the past year.
Subjects who participated in another clinical trial within 1 month prior to screening.
Subjects whose female partners are <18 years of age, or whose partners are known to be pregnant at screening, unwilling to use appropriate contraception during the study, or are breastfeeding.
Subjects whose partners have gynecological conditions that may affect sexual activity or other medical conditions limiting their participation in the clinical trial.
Subjects deemed unsuitable for inclusion by the Investigator for any other reason.