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

Sponsor

Vigonvita Life Sciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05388825

Collaborator

(none)

Enrollment

Locations

Arms

7.9

Anticipated Duration (Months)

10.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: TPN171H 2.5mg Drug: TPN171H 5mg Drug: TPN171H 10mg Drug: Placebo 5mg Drug: Placebo 10mg	Phase 2

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Three-way Crossover Clinical Trial to Evaluate the Pharmacodynamic Effect of Different Doses of TPN171H Tablets in Mild to Moderate Male Erectile Dysfunction

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: TPN171H 2.5mg TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: TPN171H 5mg TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 5mg Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 10mg Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Experimental: 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.	Drug: TPN171H 2.5mg TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: TPN171H 5mg TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 5mg Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 10mg Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Experimental: 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.	Drug: TPN171H 2.5mg TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: TPN171H 5mg TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 5mg Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 10mg Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Experimental: 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.	Drug: TPN171H 5mg TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: TPN171H 10mg TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 5mg Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 10mg Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Experimental: 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.	Drug: TPN171H 5mg TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: TPN171H 10mg TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 5mg Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 10mg Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Experimental: 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.	Drug: TPN171H 5mg TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: TPN171H 10mg TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 5mg Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) Drug: Placebo 10mg Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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）]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230022
2	Peking University Third Hospital	Beijing	Beijing	China	100191
3	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	35004
4	Henan Provincial People's Hospital	Zhenzhou	Henan	China	450003
5	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China	210008
6	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
7	The First Hospital of Jilin University	Changchun	Jinlin	China	130021
8	The Second Hospital of Dalian Medical University	Dalian	Liaoning	China	116011

Sponsors and Collaborators

Vigonvita Life Sciences

Investigators

Principal Investigator: Hui Jiang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vigonvita Life Sciences

ClinicalTrials.gov Identifier:

NCT05388825

Other Study ID Numbers:

TPN171H-E202

First Posted:

May 24, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erectile Dysfunction

Study Results

No Results Posted as of Aug 17, 2022