Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction

June 21, 2023 updated by: Vigonvita Life Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
255

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • The First affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou First People's Hospital
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Henan
      • Zhengzhou, Henan, China, 450100
        • Henan Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410000
        • The Third Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
      • Suzhou, Jiangsu, China, 215000
        • Second Affiliated Hospital of Suzhou University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • The First Affiliated Hospital of Nanchang University
    • Jinlin
      • Changchun, Jinlin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TPN171H 5mg group
TPN171H 5mg tablet + Placebo 10mg 2 tablets
Drug: TPN171H
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
Other Names:
  • Simmerafil
Experimental: TPN171H 10mg group
TPN171H 10mg tablet + Placebo 5mg tablet+ Placebo 10mg tablet
Drug: TPN171H
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
Other Names:
  • Simmerafil
Experimental: TPN171H 20mg group
TPN171H 10mg 2 tablets + Placebo 5mg tablet
Drug: TPN171H
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
Other Names:
  • Simmerafil
Placebo Comparator: Placebo group
Placebo 5mg tablet+ Placebo 10mg 2 tablets
Drug: placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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 .
baseline and 8 weeks
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses
Time Frame: baseline and 8 weeks
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.
baseline and 8 weeks
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses
Time Frame: baseline and 8 weeks
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.
baseline and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions
Time Frame: baseline ,4 weeks and 8 weeks
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.
baseline ,4 weeks and 8 weeks
Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF) ,Sexual Desire
Time Frame: baseline ,4 weeks and 8 weeks
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.
baseline ,4 weeks and 8 weeks
Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Intercourse Satisfaction
Time Frame: baseline ,4 weeks and 8 weeks
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.
baseline ,4 weeks and 8 weeks
Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction
Time Frame: baseline ,4 weeks and 8 weeks
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.
baseline ,4 weeks and 8 weeks
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses
Time Frame: baseline and 4 weeks
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.
baseline and 4 weeks
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses
Time Frame: baseline and 4 weeks
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.
baseline and 4 weeks
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 8
Time Frame: baseline ,4 weeks and 8 weeks
Assessed was the changes in the number of subjects whose IIEF domain score at the 8th week visit was ≥26.
baseline ,4 weeks and 8 weeks
Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.
Time Frame: baseline ,4 weeks and 8 weeks
Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.
baseline ,4 weeks and 8 weeks
Subgroup analysis based on the time intervals between meal and medication.
Time Frame: baseline ,4 weeks and 8 weeks
Subgroup analysis based on the time intervals between meal and medication.
baseline ,4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vigonvita Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hui Jiang, MD, PhD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TPN171H-E201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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