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A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of Alex Aildenafil Citrate Tablets in Male Patients with Erectile Dysfunction(ED)

A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of Alex Aildenafil Citrate Tablets in Male Patients with Erectile Dysfunction(ED)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070771
Enrollment
Unknown
Registered
2023-04-23
Start date
2023-02-22
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction(ED)

Interventions

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Male subjects, age = 18 years old. (2) Those who meet the diagnostic criteria of erectile dysfunction. (3) Subjects voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Patients whose anatomical or structural of penis are abnormalities with clinical significance determined by researchers(including but not limited to), such as small penis, congenital curvature of penis, cavernous fibrosis, Peyronie's disease, etc. (2) Those who are suffering from diseases that may cause abnormal erection of the penis(including but not limited to), such as sickle cell anemia, multiple myeloma, leukemia, etc. (3) Those who are suffering from severe liver injury, recent stroke or myocardial infarction, initial severe hypotension(blood pressure lower than 90/50 mmHg), non-arterial anterior ischemic optic neuropathy (NAION), and other serious diseases affecting the survival of the subjects. (4) Those who are currently taking any dosage forms of nitrates or NO donors, such as nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, etc. (5) People who are known to be allergic to aildenafil citrate or have a history of allergy to type 5 phosphodiesterase (PDE5) inhibitors. (6) Patients deemed unsuitable for participation in this trial by researchers.

Design outcomes

Primary

MeasureTime frame
International Index of Erectile Function-5,IIEF-5;Global Assessment Question,GAQ;International Index of Erectile Function-Erectile Function domain,IIEF-EF;

Countries

China

Contacts

Public ContactZhichao Zhang

Peking University First Hospital

zhangzhichao@bjmu.edu.cn+86 13501219421

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026