Moderate to Severe Erectile Dysfunction (ED) associated with Type 2 Diabetes Mellitus
Conditions
Interventions
Group 1:Low-dose single administration
Group 2:Medium-dose single administration
Group 3:High-dose single administration
Group 4:Based on the results of the phase 1 study, the optimal dose level was selected as the dose to be administered in phase 2, with one injection administered at 4-week intervals for a total of two
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-60 years (inclusive of 18 and 60 years) and male; (2) Patients with type 2 diabetes mellitus with normal glycemic control (glycosylated hemoglobin (HbA1c) = 6 months; (4) Patients who have been ineffective for 3 months after PDE5i standard treatment (regular use of tadalafil 5 mg once a night or sildenafil 100 mg temporarily 2 hours before sexual intercourse); (Ineffective: no improvement in IIEF-5 score after 3 months of treatment) (5) Have a regular female sexual partner at least 3 months prior to the first dose and during the course of this trial, and expect to maintain a sexual life with the female sexual partner during the trial; (6) Agree to attempt sexual intercourse at least 4 times every 4 weeks during the trial; (7) Agree to use effective contraception during the trial and within 3 months after the end of the trial; (8) Subjects voluntarily participated and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Congenital malformations and anatomical abnormalities of the genitals (e.g., micropenis, congenital curvature of the penis, cavernous fibrosis, etc.) that markedly impair penile erection or a rash or infectious injury on the penis or in the area around the penis, or a contagious skin disease or venereal disease. (2) Comorbid hypogonadism or hyperprolactinemia. (3) Psychological erectile dysfunction. (4) Prior history of severe cardiac disease, including but not limited to: a. Myocardial infarction, shock, or life-threatening arrhythmia within 6 months prior to enrollment; b.Unstable angina or undergone coronary artery bypass grafting or percutaneous coronary intervention within 3 months prior to enrollment; c. had angina pectoris during sexual intercourse; d. those with heart failure (NYHA classification >= II). (5) Have received any of the following treatments: a.Pelvic surgery or any other operation that invades the pelvis (e.g., prostatectomy, pelvic surgery to remove a malignant tumor, or bowel resection); b.Radiation therapy to the pelvis; c.Any pelvic surgery of the urinary tract (including minimally invasive treatment of lower urinary tract symptoms due to benign prostatic hyperplasia and penile prosthesis implantation); d. Stem cell therapy. (6) ALT and AST >= 1.5 times the upper limit of normal and SCr > upper limit of normal. (7) Comorbid tumor disease or previous history of tumor (except for eradicated squamous cell carcinoma of the skin and basal cell carcinoma of the skin). (8) Positive for any one of a full set of infectious disease tests, including Hepatitis B V, Hepatitis C, Hepatitis E, Syphilis, and Human Immunodeficiency Virus (HIV). (9) Known or suspected allergy or serious adverse reaction to the ingredients of the investigational preparation. (10) Persons with co-morbid psychiatric disorders who are unable to cooperate with the trial. (11) Participants who have participated in other clinical studies in the 3 months prior to the trial. (12) Other conditions that the investigator considers unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT) incidence;Incidence of adverse events and serious adverse events;The incidence of adverse reactions, severe adverse reactions, and local adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in IIEF-EF specific score;Proportion of subjects with an IIEF-EF specific score = 21 points;Proportion of subjects with IIEF-EF special score = 26 points;Change from baseline in erection hardness rating (EHS);Change from baseline in the proportion of subjects who answered "yes" to Sex Life Diary Question 2 (SEP2) and Sex Life Diary Question 3 (SEP3);Proportion of subjects with a change in the value of the erectile hardness rating (EHS) = grade 3;Change from baseline in the duration of erection = 60% hardness of the penile head in the nocturnal erection hardness monitoring (NPTR);Change from baseline in vascular function indexes (systolic peak flow velocity PSV, end-diastolic flow velocity EDV, resistance index RI); | — |
Countries
China
Contacts
Public ContactMujun Lu
Renji Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed