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CompletedNCT05388825Updated Feb 23, 2023

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

A Phase 2 interventional study of TPN171H 2.5mg and TPN171H 5mg in Erectile Dysfunction, sponsored by Vigonvita Life Sciences. Completed at 8 sites in China. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Vigonvita Life Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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).

02

Conditions studied

  • Erectile Dysfunction

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 84 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Vigonvita Life Sciences is the lead sponsor of 35 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (actual)

Study arms

  • 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 · Drug: TPN171H 5mg · Drug: Placebo 5mg · Drug: Placebo 10mg

  • 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 · Drug: TPN171H 5mg · Drug: Placebo 5mg · Drug: Placebo 10mg

  • 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 · Drug: TPN171H 5mg · Drug: Placebo 5mg · Drug: Placebo 10mg

  • 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 · Drug: TPN171H 10mg · Drug: Placebo 5mg · Drug: Placebo 10mg

  • 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 · Drug: TPN171H 10mg · Drug: Placebo 5mg · Drug: Placebo 10mg

  • 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 · Drug: TPN171H 10mg · Drug: Placebo 5mg · Drug: Placebo 10mg

Interventions

  • DrugTPN171H 2.5mg

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

  • DrugTPN171H 5mg

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

  • DrugTPN171H 10mg

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

  • DrugPlacebo 5mg

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

  • DrugPlacebo 10mg

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

06

What researchers measure

Primary outcomes

  1. 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）

Secondary outcomes

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

    Time frame: Baseline and during audiovisual sexual stimulation（60minutes）

  2. 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）

  3. Percentage increase in penile enlargement

    Time frame: Baseline and during audiovisual sexual stimulation（60minutes）

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

    Time frame: Baseline and during audiovisual sexual stimulation（60minutes）

07

Study locations

8 sites
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230022, China
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian 35004, China
  • Henan Provincial People's Hospital
    Zhenzhou, Henan 450003, China
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu 210008, China
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
  • The First Hospital of Jilin University
    Changchun, Jinlin 130021, China
  • The Second Hospital of Dalian Medical University
    Dalian, Liaoning 116011, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05388825
Lead sponsor
Vigonvita Life Sciences
Responsible party
Sponsor
First posted
May 24, 2022
Start date
Aug 1, 2022
Primary completion
Jan 4, 2023
Completion
Feb 17, 2023
Last update
Feb 23, 2023

Study contacts

Hui Jiang
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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