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Erectile DysfunctionPhase 3NCT06301854

Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

A Phase 3 study testing TPN171H in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 34 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 is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
TPN171H
Could I receive a placebo?
No, everyone receives an active treatment
How many people
472 participants
Where
34 sitesChina
Study dates
12 Apr 2024to 5 Jun 2025
Phase
Phase 3
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 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years to 75 years (inclusive);
  • Males with ED at least 3 months;
  • IIEF-5 ≤ 21 at visit 1;
  • Patients in a stable, heterosexual relationship during the study;
  • At the end of the untreated baseline period, the following conditions are met：（1）The subject must make at least four attempts at sexual intercourse during the untreated baseline period. （2）At least 50% of attempts during this period must be unsuccessful,（unsuccess means at least one of the first three questions should be answered "No" in SEP）.（3）5≤IIEF-EF≤25.
  • Patients who are willing to have 4 or more attempts of sexual intercourse per month, demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
  • Patients who are willing to take proper contraceptive during the study and within 3 months after the last dose;
  • 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 22Show fewer
  • Patients who do not respond to marketed PDE5 inhibitors or have adverse reactions that lead to drug discontinuation;
  • CYP3A4 potent inhibitors, moderate inhibitors, and potent inducers need to be used during the trial or discontinued for less than 31 days before enrollment;
  • Subjects who are taking nitrate or NO donor drugs, guanylate cyclase agonists and cannot be discontinued during the trial;
  • Patients with the following cardiovascular disease: Myocardial infarction or stroke within the last 6 months; Unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months;
  • Uncontrolled hypotension (<90/60mmHg) or uncontrolled hypertension (≥180/110mmHg);
  • Patients with diabetic complications (diabetic nephropathy, peripheral neuropathy);
  • Patients with hepatic or renal dysfunction as per the following: AST, ALT>3*ULN, serum creatinine exceeds 50% 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 who are unable or unwilling to cooperate;
  • Patients whose partner is breastfeeding/pregnant/trying to become pregnant, has a gynecological disease or is restricted in their activities during treatment;
  • Patients who have used other drugs in clinical trials within the last 1 month;
  • For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

China34 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100032

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

    Changsha, Hunan

  • Nuclear Industry 416 Hospital

    Chengdu, Sichuang

  • The Affiliated Hospital of Chengdu University

    Chengdu, Sichuang

  • Chifeng Municipal Hospital

    Chifeng, Neimenggu

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510000

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510700

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The 2nd Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Loudi Central Hospital

    Loudi, Hunan

  • Nanchang reproductive hospital

    Nanchang, Jiangxi, 330001

  • Qingyuan People's Hospital

    Qingyuan, G

  • Shantou Central Hospital

    Shantou, Guangdong

  • The Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong

  • Shenzhen Songgang People's Hospital

    Shenzhen, Guangdong, 518105

  • The Second Hospital of Hebei Medical Uniyersity

    Shijiazhuang, Hebei

  • Suining Central Hospital

    Suining, Sichuang

  • Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215000

  • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

    Ürümqi, Xinjiang

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xian, Shanxi

  • Xianyang Central Hospital

    Xianyang, Shanxi

  • Xingtai People's Hospital

    Xingtai, Hebei

  • The Affiliated Hospital of Qinghai University

    Xining, Qinghai

  • Yichang Central People's Hospital (Xiling Campus)

    Yichang, Jiangxi

  • Yueyang People's Hospital

    Yueyang, Hunan

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450100

  • The First Affiliated Hospital of Henan University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multicenter, Open Study to Evaluate the Long-term Safety and Efficacy of TPN171H in Patients With Erectile Dysfunction

This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction.

Being tested
TPN171H
Medical subject headings
Erectile Dysfunction

What participants receive

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

  • TPN171HDrug

    Also called Simmerafil

    10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.

Study groups in NCT06301854
Study groupRoleWhat they receive
TPN171H groupExperimental10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.
Receives: Drug: TPN171H

What is being measured

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

  1. Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation.

    Adverse events occurring throughout the study period were assessed and graded.

    Measured: during the treatment and observation.

Secondary outcomes (12)

  1. Change From Baseline in the International Index of Erectile Function - Erectile Function.

    The primary efficacy variable was the change in the EF domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 1-5 and 15 from the IIEF questionnaire .

    Measured: baseline，3 months, 6 months

  2. Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses.

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina when you are trying to have sex ?" Data are presented as the mean percentage of yes responses per participant.

    Measured: baseline，3 months, 6 months

  3. Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses.

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.

    Measured: baseline，3 months, 6 months

  4. Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication.

    Assessed was the changes in the number of subjects whose IIEF domain score at the 6th month visit was ≥26.

    Measured: baseline，3 months, 6 months

  5. Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction.

    Self-reported, Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction.

    Measured: baseline，3 months, 6 months

  6. Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month.

    Percentage of respondents who answered "yes" to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of "yes" answers per participant.

    Measured: 3 months, 6 months

  7. Change From Baseline in the International Index of Erectile Function - Erectile Function.

    The primary efficacy variable was the change in the EF domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 1-5 and 15 from the IIEF questionnaire .

    Measured: baseline，3 months, 6 months, 9 months and 12 months

  8. Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responses.

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina when you are trying to have sex ?" Data are presented as the mean percentage of yes responses per participant.

    Measured: baseline，3 months, 6 months, 9 months and 12 months

  9. Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses.

    Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.

    Measured: baseline，3 months, 6 months, 9 months and 12 months

  10. Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication.

    Assessed was the changes in the number of subjects whose IIEF domain score at the 3rd，6th，9th，12th month visit was ≥26.

    Measured: baseline，3 months, 6 months, 9 months and 12 months

  11. Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction.

    Self-reported, Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction.

    Measured: baseline, 3 months, 6 months, 9 months and 12 months

  12. Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month .

    Percentage of respondents who answered "yes" to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of "yes" answers per participant.

    Measured: 3 months, 6 months, 9 months and 12 months

Timeline

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

  1. First posted8 Mar 2024
  2. Study start12 Apr 2024
  3. Primary completion5 Jun 2025
  4. Study completion5 Jun 2025

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
472 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06301854
Sponsor's protocol ID
TPN171H-E302
Status last verified
Jul 2025
First submitted
3 Mar 2024
Last updated
25 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TPN171H in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 34 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 8 inclusion and 22 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation. (time frame: during the treatment and observation.). 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 NCT06301854.

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 25 Jul 2025.

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