Efficacy and safety of pancreatic kininogenase in the treatment of diabetes mellitus-associated erectile dysfunction

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100047068

Enrollment

Unknown

Registered

2021-06-07

Start date

2021-06-15

Completion date

Unknown

Last updated

2022-01-18

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

Conditions

diabetes mellitus-associated erectile dysfunction

Interventions

Experimental group:pancreatic kininogenase 240u / TID, tadalafil tablets 5mg / QD

Control group:tadalafil tablets 5mg / QD

Eligibility

Sex/Gender

Male

Age

30 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Married male subjects, aged 30 to 50 years; 2. According to the diagnostic criteria and classification of diabetes in WHO 1999, it belongs to type 2 diabetes mellitus (T2DM); 3. The IIEF-5 score was 8-21. The patient had a history of at least 3 months and had a stable relationship with his wife in the past 6 months; 4. The patient agreed to participate in the clinical study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with mental and psychological disorders and liver and kidney dysfunction; 2.Major central nervous system injury in the past 6 months; 3.In recent 2 months, there were heart failure, acute coronary syndrome, acute myocardial infarction, inflammation, ulcer, trauma, bleeding and other patients; 4.History of ED caused by other primary sexual dysfunction, including premature ejaculation or ed caused by untreated endocrine diseases (such as hypopituitarism, hypothyroidism or hypogonadism); 5.Erectile dysfunction patients caused by related drugs and mental diseases; 6.The researchers believe that there are penile deformities with clinical significance; 7.Patients with history of penile prosthesis implantation; 8.Allergic constitution or allergic to the drug used in this study; 9.Those who can not complete the basic treatment of blood glucose control; 10.The patients who used endothelial function protectors in the past 2 weeks; 11.Those who need androgen therapy; 12.The attending doctors thought that they were not suitable for the clinical study.

Design outcomes

Primary

Measure	Time frame
Efficacy evaluation;Safety;	—

Countries

China

Contacts

Public ContactLi Hongjun

Department of Urology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

lihongjun@pumch.cn+86 13901171724

Outcome results

None listed

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