AzTrials
AzTrials

Erectile DysfunctionPhase 2NCT04479917

Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction

A Phase 2 study testing TPN171H in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 12 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 an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg, 20mg or placebo administered orally in patients with erectile dysfunction. Read more about this study

Who is it for?
Ages 22 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
TPN171H
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
12 sitesChina
Study dates
23 Jul 2020to 26 Jul 2021
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 22 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients aged ≥22 with ED, defined as an inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse, evident for at least 3 months;
  • Patients whose IIEF-EF domain score is < 26;
  • 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 each 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 study completed;
  • Patients who have voluntarily decided to participate in this study, and signed the informed consent form.

Who cannot join

  • 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, like hypopituitarism, hypothyroidism, or hypogonadism.
  • 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 a history of hypersensitivity to other PDE5 inhibitors or who have not responded to them;
Show all 20Show fewer
  • 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 (≥160/95mmHg); Orthostatic hypotension.
  • Patients administered with the following medications:
  • Nitrate/Nitric oxide (NO) donors; Androgens, anti-androgen, trazodone; Agents that significantly affect the CYP3A4 intermediary metabolism.
  • Diabetic patients whose FBS is over 1.5 fold of normal value, or whose HbA1c exceeds 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;
  • Patient with a history of malignancy;
  • Patients with a major refractory psychiatric disorder or significant neurological abnormalities;
  • Patients with alcohol addiction or persistent abuse of drugs of dependence;
  • Patients who are participating or discontinued participation in the past 3 months from any other clinical trial, or are planning to father a baby or are in a relationship with a pregnant partner.
  • 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

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University

    Changchun, Jinlin, 130021

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Second Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450100

Other trials in China

About this study

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

This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg, 20mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, TPN171H 5mg, 10mg or 20mg 30 minutes to 4 hours before sexual intercourse for 8 weeks.

Read the detailed description

This is a Phase II study in 240 ED patients, which consists of 3 part: 1) a 4-week run-in period without any ED treatment; 2)randomization to 8 weeks of treatment with TPN171H or placebo; and 3) a 1-week follow-up period for continued adverse event monitoring.

The effects of TPN171H on ED will be evaluated using the IIEF-EF and SEP diaries. The IIEF-EF will be administered at baseline and at 4-week intervals following initiation of treatment, meanwhile the SEP diary will be completed by patients after each sexual attempt throughout the study.

Being tested
TPN171H, placebo
Keywords
Erectile Dysfunction, TPN171H, Simmerafil
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

    Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

  • placeboDrug

    Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Study groups in NCT04479917
Study groupRoleWhat they receive
TPN171H 5mg groupExperimentalTPN171H 5mg tablet + Placebo 10mg 2 tablets
Receives: Drug: TPN171H
TPN171H 10mg groupExperimentalTPN171H 10mg tablet + Placebo 5mg tablet+ Placebo 10mg tablet
Receives: Drug: TPN171H
TPN171H 20mg groupExperimentalTPN171H 10mg 2 tablets + Placebo 5mg tablet
Receives: Drug: TPN171H
Placebo groupPlacebo comparatorPlacebo 5mg tablet+ Placebo 10mg 2 tablets
Receives: Drug: placebo

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 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 and 8 weeks

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

  3. Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 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 8 weeks

Secondary outcomes (9)

  1. Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions

    Self-reported Orgasmic Functions over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.

    Measured: baseline ,4 weeks and 8 weeks

  2. Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF) ,Sexual Desire

    Self-reported Sexual Desire over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.

    Measured: baseline ,4 weeks and 8 weeks

  3. Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Intercourse Satisfaction

    Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.

    Measured: baseline ,4 weeks and 8 weeks

  4. Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction

    Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.

    Measured: baseline ,4 weeks and 8 weeks

  5. 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?" Data are presented as the mean percentage of yes responses per participant.

    Measured: baseline and 4 weeks

  6. 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 and 4 weeks

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

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

    Measured: baseline ,4 weeks and 8 weeks

  8. Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.

    Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.

    Measured: baseline ,4 weeks and 8 weeks

  9. Subgroup analysis based on the time intervals between meal and medication.

    Subgroup analysis based on the time intervals between meal and medication.

    Measured: baseline ,4 weeks and 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 posted21 Jul 2020
  2. Study start23 Jul 2020
  3. Primary completion26 Jul 2021
  4. Study completion26 Jul 2021

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479917
Sponsor's protocol ID
TPN171H-E201
Status last verified
Dec 2021
First submitted
11 Jul 2020
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang Y, Jiang T, Zhao L, Zhang X, Deng J, Dai Y, Zhou H, Juan J, Duan H, Jiang H. Efficacy and safety of simenafil in men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group, phase 2 trial. J Sex Med. 2026 May 9;23(6):qdag075. doi: 10.1093/jsxmed/qdag075.

    PubMed 42114123

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TPN171H in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 12 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 7 inclusion and 20 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 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?

Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 8 (time frame: baseline and 8 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 NCT04479917, 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 22 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in