- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05388825
Pharmacodynamic Study of TPN171H Tablets in Patients With Mild to Moderate Erectile Dysfunction
February 22, 2023 updated by: Vigonvita Life Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anhui
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Hefei, Anhui, China, 230022
- The First Affiliated Hospital of Anhui Medical University
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Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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Fujian
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Fuzhou, Fujian, China, 35004
- The First Affiliated Hospital of Fujian Medical University
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Henan
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Zhenzhou, Henan, China, 450003
- Henan Provincial People's Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Nanjing Drum Tower Hospital
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Suzhou, Jiangsu, China, 215006
- The First Affiliated Hospital of Soochow University
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Jinlin
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Changchun, Jinlin, China, 130021
- The First Hospital of Jilin University
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Liaoning
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Dalian, Liaoning, China, 116011
- The Second Hospital of Dalian Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
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.
|
TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
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.
|
TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
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.
|
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 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.
|
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 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.
|
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Time Frame: Baseline and during audiovisual sexual stimulation(60minutes)
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Baseline and during audiovisual sexual stimulation(60minutes)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The starting time of penile erections of greater than or equal to 60% rigidity
Time Frame: Baseline and during audiovisual sexual stimulation(60minutes)
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Baseline and during audiovisual sexual stimulation(60minutes)
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Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Time Frame: Baseline and during audiovisual sexual stimulation(minutes)
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Baseline and during audiovisual sexual stimulation(minutes)
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Percentage increase in penile enlargement
Time Frame: Baseline and during audiovisual sexual stimulation(60minutes)
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Baseline and during audiovisual sexual stimulation(60minutes)
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The incidence of penile erection rigidity grade ≥ grade III.
Time Frame: Baseline and during audiovisual sexual stimulation(60minutes)
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Baseline and during audiovisual sexual stimulation(60minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
January 4, 2023
Study Completion (Actual)
February 17, 2023
Study Registration Dates
First Submitted
May 18, 2022
First Submitted That Met QC Criteria
May 18, 2022
First Posted (Actual)
May 24, 2022
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPN171H-E202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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