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

NCT05388825 | Completed Phase 2

• 1 other identifier: TPN171H-E202
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 8

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).

  Baseline and during audiovisual sexual stimulation（60minutes）

Secondary Outcomes (4)

• The starting time of penile erections of greater than or equal to 60% rigidity

  Baseline and during audiovisual sexual stimulation（60minutes）

• Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).

  Baseline and during audiovisual sexual stimulation（minutes）

• Percentage increase in penile enlargement

  Baseline and during audiovisual sexual stimulation（60minutes）

• The incidence of penile erection rigidity grade ≥ grade III.

  Baseline and during audiovisual sexual stimulation（60minutes）

Study Arms (6)

Sequence 1

EXPERIMENTAL

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.

Drug: TPN171H 2.5mg; Drug: TPN171H 5mg; Drug: Placebo 5mg; Drug: Placebo 10mg

Sequence 2

EXPERIMENTAL

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.

Drug: TPN171H 2.5mg; Drug: TPN171H 5mg; Drug: Placebo 5mg; Drug: Placebo 10mg

Sequence 3

EXPERIMENTAL

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.

Drug: TPN171H 2.5mg; Drug: TPN171H 5mg; Drug: Placebo 5mg; Drug: Placebo 10mg

Sequence 4

EXPERIMENTAL

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.

Drug: TPN171H 5mg; Drug: TPN171H 10mg; Drug: Placebo 5mg; Drug: Placebo 10mg

Sequence 5

EXPERIMENTAL

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.

Drug: TPN171H 5mg; Drug: TPN171H 10mg; Drug: Placebo 5mg; Drug: Placebo 10mg

Sequence 6

EXPERIMENTAL

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.

Drug: TPN171H 5mg; Drug: TPN171H 10mg; Drug: Placebo 5mg; Drug: Placebo 10mg

Interventions

TPN171H 2.5mg DRUG

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

Sequence 1; Sequence 2; Sequence 3

TPN171H 5mg DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

TPN171H 10mg DRUG

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

Sequence 4; Sequence 5; Sequence 6

Placebo 5mg DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo 10mg DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (8)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 35004, China

Location

Henan Provincial People's Hospital

Zhenzhou, Henan, 450003, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Hospital of Jilin University

Changchun, Jinlin, 130021, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hui Jiang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: August 1, 2022
• Primary Completion: January 4, 2023
• Study Completion: February 17, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)