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Erectile DysfunctionPhase 2NCT05388825

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

A Phase 2 study testing TPN171H 2.5mg, TPN171H 5mg and TPN171H 10mg in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
TPN171H 2.5mg, TPN171H 5mg and TPN171H 10mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
8 sitesChina
Study dates
1 Aug 2022to 17 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University

    Changchun, Jinlin, 130021

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 35004

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Henan Provincial People's Hospital

    Zhenzhou, Henan, 450003

Other trials in China

About this study

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

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).

Being tested
TPN171H 2.5mg, TPN171H 5mg, TPN171H 10mg, Placebo 5mg, Placebo 10mg
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPN171H 2.5mgDrug

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

  • TPN171H 5mgDrug

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

  • TPN171H 10mgDrug

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

  • Placebo 5mgDrug

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

  • Placebo 10mgDrug

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

Study groups in NCT05388825
Study groupRoleWhat they receive
Sequence 1ExperimentalN=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.
Receives: Drug: TPN171H 2.5mg; Drug: TPN171H 5mg; Drug: Placebo 5mg; Drug: Placebo 10mg
Sequence 2ExperimentalN=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.
Receives: Drug: TPN171H 2.5mg; Drug: TPN171H 5mg; Drug: Placebo 5mg; Drug: Placebo 10mg
Sequence 3ExperimentalN=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.
Receives: Drug: TPN171H 2.5mg; Drug: TPN171H 5mg; Drug: Placebo 5mg; Drug: Placebo 10mg
Sequence 4ExperimentalN=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.
Receives: Drug: TPN171H 5mg; Drug: TPN171H 10mg; Drug: Placebo 5mg; Drug: Placebo 10mg
Sequence 5ExperimentalN=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.
Receives: Drug: TPN171H 5mg; Drug: TPN171H 10mg; Drug: Placebo 5mg; Drug: Placebo 10mg
Sequence 6ExperimentalN=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.
Receives: Drug: TPN171H 5mg; Drug: TPN171H 10mg; Drug: Placebo 5mg; Drug: Placebo 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and during audiovisual sexual stimulation（60minutes）

Secondary outcomes (4)

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

    Measured: 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).

    Measured: Baseline and during audiovisual sexual stimulation（minutes）

  3. Percentage increase in penile enlargement

    Measured: Baseline and during audiovisual sexual stimulation（60minutes）

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

    Measured: Baseline and during audiovisual sexual stimulation（60minutes）

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start1 Aug 2022
  3. Primary completion4 Jan 2023
  4. Study completion17 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388825
Sponsor's protocol ID
TPN171H-E202
Status last verified
Feb 2023
First submitted
18 May 2022
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Z, Jiang T, Dai YT, Zhang XS, Huang YH, Zhang XS, Zhou HL, Juan JX, Duan HQ, Jiang H. Efficacy and safety of simenafil in erectile dysfunction: a phase II, randomized, double-blind, placebo-controlled, crossover study. Asian J Androl. 2026 Sep 11. doi: 10.4103/aja202622. Online ahead of print.

    PubMed 42725809

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TPN171H 2.5mg, TPN171H 5mg and TPN171H 10mg in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05388825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.

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