Pharmacodynamic Study of TPN171H Tablets in Patients With Mild to Moderate Erectile Dysfunction

NCT ID: NCT05388825

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-02-17

Brief Summary

This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial design.

Detailed Description

This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial design. The pharmacodynamic effects of different doses of TPN171H tablets on mild to moderate male patients with erectile dysfunction were evaluated by penile plethysmography (RigiScan PlusTM technique) using audiovisual sexual stimulation (AVSS).

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1

N=14 subjects receive 2.5 mg TPN171H and 10 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2 ; 10 mg Placebo and 5 mg Placebo for Period 3.

Group Type: EXPERIMENTAL

TPN171H 2.5mg

Intervention Type: DRUG

TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

TPN171H 5mg

Intervention Type: DRUG

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 5mg

Intervention Type: DRUG

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 10mg

Intervention Type: DRUG

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Sequence 2

N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2 ; 2.5 mg TPN171H and 10 mg Placebo for Period 3.

Group Type: EXPERIMENTAL

TPN171H 2.5mg

Intervention Type: DRUG

TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

TPN171H 5mg

Intervention Type: DRUG

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 5mg

Intervention Type: DRUG

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 10mg

Intervention Type: DRUG

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Sequence 3

N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 2.5 mg TPN171H and 10 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.

Group Type: EXPERIMENTAL

TPN171H 2.5mg

Intervention Type: DRUG

TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

TPN171H 5mg

Intervention Type: DRUG

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 5mg

Intervention Type: DRUG

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 10mg

Intervention Type: DRUG

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Sequence 4

N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg TPN171H and 5 mg Placebo for Period 2; 10 mg Placebo and 5 mg Placebo for Period 3.

Group Type: EXPERIMENTAL

TPN171H 5mg

Intervention Type: DRUG

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

TPN171H 10mg

Intervention Type: DRUG

TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 5mg

Intervention Type: DRUG

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 10mg

Intervention Type: DRUG

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Sequence 5

N=14 subjects receive 10 mg TPN171H and 5 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.

Group Type: EXPERIMENTAL

TPN171H 5mg

Intervention Type: DRUG

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

TPN171H 10mg

Intervention Type: DRUG

TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 5mg

Intervention Type: DRUG

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 10mg

Intervention Type: DRUG

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Sequence 6

N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2; 10 mg TPN171H and 5 mg Placebo for Period 3.

Group Type: EXPERIMENTAL

TPN171H 5mg

Intervention Type: DRUG

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

TPN171H 10mg

Intervention Type: DRUG

TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 5mg

Intervention Type: DRUG

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Placebo 10mg

Intervention Type: DRUG

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Interventions

TPN171H 2.5mg

TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Intervention Type: DRUG

TPN171H 5mg

TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Intervention Type: DRUG

TPN171H 10mg

TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Intervention Type: DRUG

Placebo 5mg

Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Intervention Type: DRUG

Placebo 10mg

Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years to 65 years (inclusive)
• Males with ED at least 6 months, meets the diagnosis of mild and moderate erectile dysfunction，8≤IIEF-5 ≤ 21
• Patients who are willing to stay away from any other medicines or treatments for ED during this study period
• Patients (including partners) 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 Criteria

• Patients who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H
• 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
• 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 not responded to PDE5 inhibitors or who have an adverse reaction leading to discontinuation
• CYP3A4 potent inhibitors, potent inducers, and moderate inducers (except topical drugs) should be used within 28 days before the start of treatment or during the trial period
• Subjects who are taking nitrate or NO donor drugs, anti-androgens, guanylate cyclase agonists, or other drugs or treatments for the treatment of ED and cannot be discontinued
• Patients with the following cardiovascular disease:

Myocardial infarction or shock, or life-threatening arrhythmia within the last 6 months; Unstable angina or angina occurring during sexual intercourse within the last 3 months; Received coronary artery bypass grafting or percutaneous coronary intervention within the last 3 months；New York Heart Association Class 2 or greater heart failure in the last 6 months

• Uncontrolled hypotension (<90/60mmHg), uncontrolled hypertension(≥160/95mmHg)
• Diabetic patients whose FBS is over 1.5 fold of normal value, or whose HbA1c >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
• Patients with a history of severe central nervous system injury or peripheral muscular neurological disease in the past 6 months
• Patient with a history of malignancy
• Patients with significant neurological abnormalities
• Patients with alcohol addiction
• Patients with persistent abuse of drugs of dependence
• Patients who have a childbirth plan during the trial period and within 3 months after the trial
• Patients who are participating in the past 3 months from any other clinical trial (except those who have participated in the clinical trials of this product before)
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Jiang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Henan Provincial People's Hospital

Zhenzhou, Henan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jinlin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Countries

China

Other Identifiers

TPN171H-E202

Identifier Type: -

Identifier Source: org_study_id