Status:
COMPLETED
Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction
Lead Sponsor:
Vigonvita Life Sciences
Collaborating Sponsors:
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Conditions:
Erectile Dysfunction
Eligibility:
MALE
22+ years
Phase:
PHASE2
Brief Summary
This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg, 20mg or placebo administe...
Detailed Description
This is a Phase II study in 240 ED patients, which consists of 3 part: 1) a 4-week run-in period without any ED treatment; 2)randomization to 8 weeks of treatment with TPN171H or placebo; and 3) a 1-w...
Eligibility Criteria
Inclusion
- Male patients aged ≥22 with ED, defined as an inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse, evident for at least 3 months;
- Patients whose IIEF-EF domain score is \< 26;
- Patients in a stable, heterosexual relationship for at least 3 months and during the study;
- Patients who are willing to stay away from any other medicines or treatments for ED during this study period;
- Patients who are willing to have 4 or more attempts of sexual intercourse each month, demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
- Patients who are willing to take proper contraceptive during the study and within 3 months after the study completed;
- Patients who have voluntarily decided to participate in this study, and signed the informed consent form.
Exclusion
- Patients with anatomical malformations of the penis;
- Patients with primary hypoactive sexual desire;
- Patients with ED, which is caused by any other primary sexual disorder, like hypopituitarism, hypothyroidism, or hypogonadism.
- Patients with ED ,which is caused by spinal injury or have had a radical prostatectomy or other surgery ;
- Patients who have a penile implant;
- Patients who have a history of hypersensitivity to other PDE5 inhibitors or who have not responded to them;
- Patients with the following cardiovascular disease:
- Myocardial infarction or stroke within the last 6 months; Unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months; Uncontrolled hypotension (\<90/60mmHg), or uncontrolled hypertension (≥160/95mmHg); Orthostatic hypotension.
- Patients administered with the following medications:
- Nitrate/Nitric oxide (NO) donors; Androgens, anti-androgen, trazodone; Agents that significantly affect the CYP3A4 intermediary metabolism.
- Diabetic patients whose FBS is over 1.5 fold of normal value, or whose HbA1c exceeds 9%, or with diabetes complications, such as diabetic nephropathy, peripheral neuropathy;
- Patients with hepatic or renal dysfunction as per the following: AST, ALT≧2\*ULN, serum creatinine exceeds 20% of the upper limit of normal value;
- Patients with active gastrointestinal ulcers and bleeding disorders;
- Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosa;
- Patients who have a history of sudden decrease or loss of hearing;
- Patient with a history of malignancy;
- Patients with a major refractory psychiatric disorder or significant neurological abnormalities;
- Patients with alcohol addiction or persistent abuse of drugs of dependence;
- Patients who are participating or discontinued participation in the past 3 months from any other clinical trial, or are planning to father a baby or are in a relationship with a pregnant partner.
- For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate due to clinically significant findings according to the medical decision of the principal investigator or the study personnel.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2021
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04479917
Start Date
July 23 2020
End Date
July 26 2021
Last Update
June 22 2023
Active Locations (12)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
4
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510000