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Erectile DysfunctionPhase 3NCT05188989

Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.

A Phase 3 study testing TPN171H 2.5mg group, TPN171H 5mg group and TPN171H 10mg group in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 49 sites in China.

Completed

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

Official record
Search all trials

Trial summary

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety 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 2.5mg group, TPN171H 5mg group and TPN171H 10mg group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
765 participants
Where
49 sitesChina
Study dates
31 Dec 2021to 14 Feb 2023
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 65 years (inclusive)
  • Males with ED at least 6 months
  • IIEF-5 ≤ 21 at visit 1
  • Patients in a stable, heterosexual relationship for at least 3 months and during the study;
  • Patients who are willing to stay away from any other medicines or treatments for ED during this study period
  • Patients who are willing to have 4 or more attempts of sexual intercourse per 4 weeks, demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
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  • Patients who are willing to take proper contraceptive during the study and within 3 months after the study completed;
  • 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 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
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  • 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 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), uncontrolled hypertension (≥160/95mmHg); Orthostatic hypotension.
  • 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 are planning to father a baby or are in a relationship with a pregnant partner.
  • 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
  • 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

49 sites in 1 country.

49 sites in 1 country

China49 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100000

  • Xiyuan Hospital china Academy of chinese Medical Sciences

    Beijing, Beijing Municipality, 100000

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The Affiliated Hospital to Changchun University of Traditional Medicine

    Changchun, Jilin, 130021

  • The Frist Hospital of Jilin University

    Changchun, Jilin, 130061

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital

    Chengdou, Sichuan, 610072

  • Clinical Medical College & Affiliated Hospital of Chengdu University

    Chengdou, Sichuan, 610081

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 35004

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510700

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570102

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230012

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Liuzhou peopleˊs Hospital

    Liuzhou, Guangxi, 545026

  • Nanchang reproductive hospital

    Nanchang, Jiangxi, 330001

  • First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Provincial Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210004

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • The Second Nanning People's Hospital

    Nanning, Guangxi, 530031

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Shanghai Ceneral Hospital

    Shanghai, Shanghai Municipality, 200940

  • Shanghai Pudong Hospital ,Fudan university PuDong Medical center

    Shanghai, Shanghai Municipality, 201399

  • Shenzhen University General Hospital

    Shenzhen, Guangdong, 518071

  • Songgang People's Hospital

    Shenzhen, Guangdong, 518105

  • The Eighth Affiliated Hospital Sun Yat-sen University

    Shenzhen, Guangdong, 528406

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

  • Tongji Medical College of HUST

    Wuhan, Hubei, 215104

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • The first affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241004

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Qinghai university affiliated hospital

    Xining, Qinghai, 810012

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

  • People's Hospital of zhengzhou

    Zhengzhou, Henan, 450053

  • Henan Provincial People's Hospital

    Zhenzhou, Henan, 450003

  • Zhuhai People's Hospital

    Zhuhai, Guangdong, 519099

Other trials in China

About this study

Official title: A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of TPN171H in Patients With Erectile Dysfunction

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of TPN171H in men with erectile dysfunction.

Being tested
TPN171H 2.5mg group, TPN171H 5mg group, TPN171H 10mg group, Placebo group
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 2.5mg groupDrug

    Also called Simmerafil

    TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse

  • TPN171H 5mg groupDrug

    Also called Simmerafil

    TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse

  • TPN171H 10mg groupDrug

    Also called Simmerafil

    TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse

  • Placebo groupDrug

    Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse

Study groups in NCT05188989
Study groupRoleWhat they receive
TPN171H 2.5mg groupExperimentalNot described
Receives: Drug: TPN171H 2.5mg group
TPN171H 5mg groupExperimentalNot described
Receives: Drug: TPN171H 5mg group
TPN171H 10mg groupExperimentalNot described
Receives: Drug: TPN171H 10mg group
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo group

What is being measured

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

  1. Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12

    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 and 12 weeks

  2. Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at 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 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 and 12 weeks

  3. Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at 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 and 12 weeks

Secondary outcomes (5)

  1. Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 4、8

    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 ,4 weeks and 8 weeks

  2. Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 4、8、12

    Assessed was the changes in the number of subjects whose IIEF domain score at the 8th week visit was ≥26.

    Measured: baseline , 4 weeks , 8 weeks ,12 weeks

  3. Change From Baseline to 4 Week , 8 Week and 12 Week 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 over the past 12 weeks.

    Measured: baseline , 4 weeks , 8 weeks ,12 weeks

  4. Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 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 , 4 weeks , 8 weeks

  5. Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 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 , 4 weeks , 8 weeks

Timeline

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

  1. First posted12 Jan 2022
  2. Study start31 Dec 2021
  3. Primary completion14 Feb 2023
  4. Study completion14 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
765 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05188989
Sponsor's protocol ID
TPN171H-E301
Status last verified
Mar 2023
First submitted
29 Dec 2021
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
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 2.5mg group, TPN171H 5mg group and TPN171H 10mg group in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 49 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 9 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 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. Some participants in this study may receive a placebo. 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?

Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 NCT05188989.

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 7 Mar 2023.

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