Erectile dysfunction in men
Conditions
Interventions
Control group:Placebo
Experimental group:CMS203 table
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
Male
Age
22 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Able to read, understand, and voluntarily sign the informed consent form. 2. Male subjects aged 22 to 65 years old (inclusive). 3. Meets the diagnostic criteria for erectile dysfunction (a male inability to consistently achieve and maintain adequate penile erections to achieve satisfactory sexual activity), with a duration of >= 3 months. 4. The International Index of Erectile Function-5 (IIEF-5) score is = 4, and the baseline IIEF-EF score should be >= 5 and <= 25. 8. Screening for patients who have not taken any other drugs for erectile dysfunction (ED) within the first week of the washout period, or who agree not to take such drugs during the trial period, or drugs that the researchers judge may affect erectile function (including chemical drugs, biologics, and traditional Chinese medicine). 9. The subjects guarantee that they have no plans for childbirth or sperm donation from the time of signing the informed consent form to 6 months after the last administration of medication, and agree to adopt any of the following contraceptive measures from the time of signing the informed consent form to the last visit: (1) The subject's sexual partner uses an intrauterine device with an annual failure rate of less than 1%; (2) The subject's sexual partner uses a cervical cap or diaphragm with spermicide; (3) The subject's sexual partner has undergone tubal sterilization; (4) The subject has undergone vasectomy; (5) Proper use of condoms.
Exclusion criteria
Exclusion criteria: 1.AI AI 1. Hypersensitivity to the components of CMS203 Tablets and its simulants, or a history of hypersensitivity to PDE5 inhibitors. 2. Clinically significant anatomical or structural abnormalities of the penis identified by researchers (including but not limited to): microphallus, congenital curvature of the penis, and cavernous fibrosis. 3. Subjects who meet any of the following criteria: (1) The investigator determines that ED is caused by sexual dysfunction, such as ejaculatory dysfunction, premature ejaculation, or the investigator is unable to determine whether ED is secondary to premature ejaculation; (2) The investigator determines that ED is caused by endocrine diseases, such as hypogonadism, hyperprolactinemia, hyperthyroidism or hypothyroidism, or Cushing's syndrome; (3) The investigator determines that ED is caused by medications, such as antihypertensive drugs, antidepressants, antipsychotics, antiandrogenic drugs, or antihistamines; (4) The investigator determines that ED is caused by spinal/nerve injury. 4. The subject was inquired to have comorbidities that are prone to cause priapism, such as sickle cell anemia, multiple myeloma, leukemia, etc. 5. Hyposexuality is the primary diagnosis. 6. Having any of the following pelvic medical histories: (1) Pelvic surgery or any other invasive procedure involving the pelvis (e.g., prostatectomy, pelvic surgery for malignant tumor removal, or bowel resection); (2) Pelvic radiation therapy; any pelvic surgical procedure involving the urinary tract (including minimally invasive BPH-LUTS treatment and penile implant surgery); (3) Lower urinary tract malignancy or trauma. 7. Abnormal electrocardiogram results with clinical significance, or a history of any of the following heart diseases: (1) myocardial infarction, shock, or life-threatening arrhythmia within the past 6 months; (2) unstable angina pectoris within the past 3 months, or having undergone coronary artery bypass graft surgery, or having undergone percutaneous coronary intervention; (3) angina pectoris during sexual activity; (4) heart failure with New York Heart Association (NYHA) classification of >= II within the past 6 months; (5) left ventricular outflow tract obstruction (such as aortic stenosis, idiopathic hypertrophic subaortic stenosis). 8. Combined with poorly controlled diabetes (fasting blood glucose >11.1 mmol/L), or with diabetic complications (such as diabetic nephropathy, peripheral neuropathy). 9. Individuals with active gastrointestinal ulcers, bleeding disorders, glaucoma, visual abnormalities (such as color vision abnormalities, pigmentary retinitis, macular degeneration), or abnormal hearing loss, who have a history of eye surgery; individuals who have previously experienced non-arteritic anterior ischemic optic neuropathy (NAION) or have a history of sudden deafness. 10. Screen for individuals with a history of severe central nervous system injury (such as cerebrovascular diseases like cerebral hemorrhage or ischemia, brain inflammatory diseases like encephalitis or meningitis, or craniocerebral trauma or spinal cord injury) or peripheral muscular nervous system diseases within the previous 6 months. 11. Individuals with a history of any malignant tumor, or other primary diseases affecting vital organs and systems such as the heart, brain, liver, kidneys, and hematopoietic system. 12. Individuals with a history of psychiatric disorders. 13. Combined wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 8 weeks of treatment during the double-blind trial period, the following indicators will be assessed: 1. Change in erectile function-specific score (IIEF-EF) from base; | — |
Secondary
| Measure | Time frame |
|---|---|
| After 4 weeks of treatment during the double-blind trial period, the following indicators will be assessed: 1. Change in erectile function-specific score (IIEF-EF) from base; | — |
Countries
China
Contacts
Public ContactDeng Chunhua
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed