None listed
Conditions
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
22 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Married male subjects aged 22-65 years; (2) According to the diagnosis of mild to moderate functional erectile dysfunction, that is, 8 points less than IIEF-5 scale score less than 21 points, and penile hardness score (EHS) is grade II-III; (3) ED patients with a history of more than 3 months and less than 7 years; (4) Patients with ED who took PDE5 inhibitors within 4 weeks before screening and were effective; (5) Voluntarily participate in the experiment and sign a written informed consent.
Exclusion criteria
Exclusion criteria: (1) Those with congenital malformation of genital organs, anatomical abnormality, other organic sexual dysfunction or history of penile prosthesis implantation with obvious impairment of penile erection; (2) Have a history of ED caused by other primary dysfunction, including premature ejaculation or ED caused by untreated endocrine diseases (e.g., hypophysis, hypothyroidism or hypogonadism); (3) Low sexual desire was the primary diagnosis; (4) ED patients who had taken drugs that might cause male erectile dysfunction within 4 weeks before screening were not ready to discontinue the treatment; (5) ED patients were treated with negative pressure aspiration (VCD), ICI therapy, NO donors and other drugs (including traditional Chinese medicine and sex hormones) four weeks before screening, and were not ready to discontinue the treatment; (6) Screening patients who have had or suffered from myocardial infarction, unstable angina pectoris or angina pectoris during intercourse, New York Heart Association (NYHA) > grade 2 heart failure, uncontrolled arrhythmia, hypotension ( 170/100 mmHg) or major central nervous system injury (including stroke or spinal cord injury) in the first six months; (7) HbA1c (> 6.5%); (8) Those currently using any nitrates, cancer chemotherapy, androgens, androgen antagonists, estrogens, luteinizing hormone releasing hormone (LHRH) agonists/antagonists, synthetic steroids, alpha-receptor blockers or potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir); (9) Patients with gastrointestinal ulcer, hemorrhagic disease or abnormal liver and kidney function (ALT, AST exceeded the upper limit of reference value by 1.5 times or Scr exceeded the upper limit of reference value); (10) Those with abnormal color vision, retinitis pigmentosa, macular degeneration, blindness due to Non-arteritis anterior ischemic optic neuropathy (NAION), or history of retinitis pigmentosa or cataract surgery; (11) No contraceptive measures (such as condoms, oral contraceptives, topical contraceptives, contraceptive sponges, spermicides, vasectomies) or those who are ready to have children or their spouses prepare for pregnancy during or within six months after the cessation of medication; (12) HBsAg, HCV antibody, HIV antibody or Treponema pallidum antibody positive; (13) Severe primary diseases, such as viral hepatitis, hemophilia and psychosis, are associated with severe heart, brain, lung, liver, kidney and blood system diseases; (14) In the past six months, there have been tobacco (smoking more than 5 cigarettes per day), alcohol (drinking more than 14 units per week: 1 unit = beer 285 ml, or spirits 25 mL, or wine 100 mL) or drug abuse history; (15) Anaphylaxis or contraindication to other PDE5 inhibitors, non-related components of Edena citrate known or suspected; (16) Those who were enrolled in clinical trials of other drugs or medical devices within the past three months; (17) Researchers believe that others are not suitable for participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of hardness (>60%) during erection of head and root of penis; | — |
Countries
China
Contacts
Public ContactZHongcheng Xin
Peking University First Hospital
Outcome results
None listed