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Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.

Sponsor
Vigonvita Life Sciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05188989
Collaborator
(none)
740
Enrollment
47
Locations
4
Arms
12
Anticipated Duration (Months)
15.7
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TPN171H 2.5mg group
  • Drug: TPN171H 5mg group
  • Drug: TPN171H 10mg group
  • Drug: Placebo group
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
740 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of TPN171H in Patients With Erectile Dysfunction
Actual Study Start Date :
Dec 31, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TPN171H 2.5mg group

Drug: TPN171H 2.5mg group
TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Other Names:
  • Simmerafil

    		•
    Experimental: TPN171H 5mg group

    Drug: TPN171H 5mg group
    TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
    Other Names:
  • Simmerafil

    		•
    Experimental: TPN171H 10mg group

    Drug: TPN171H 10mg group
    TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse
    Other Names:
  • Simmerafil

    		•
    Placebo Comparator: Placebo group

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

    Outcome Measures

    Primary Outcome Measures

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

    2. Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses [baseline and 12 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.

    3. Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses [baseline and 12 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.

    Secondary Outcome Measures

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

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

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

    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 [baseline , 4 weeks , 8 weeks ,12 weeks]

      Self-reported ,Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction over the past 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 [baseline , 4 weeks , 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.

    5. Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses [baseline , 4 weeks , 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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;

    • 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.

    Exclusion Criteria:

    • 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

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second People's Hospital of Hefei Hefei Anhui China 230012
    2 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230022
    3 The Second Hospital of Anhui Medical University Hefei Anhui China 230601
    4 The first affiliated Hospital of Wannan Medical College Wuhu Anhui China 241004
    5 Peking Union Medical College Hospital Beijing Beijing China 100000
    6 Peking University Shougang Hospital Beijing Beijing China 100000
    7 Xiyuan Hospital china Academy of chinese Medical Sciences Beijing Beijing China 100000
    8 Peking University Third Hospital Beijing Beijing China 100191
    9 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 35004
    10 The First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003
    11 Lanzhou University Second Hospital Lanzhou Gansu China 730030
    12 Guangzhou First People's Hospital Guangzhou Guangdong China 510180
    13 Southern Medical University Nanfang Hospital Guangzhou Guangdong China 510515
    14 The Fifth Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510700
    15 Shenzhen University General Hospital Shenzhen Guangdong China 518071
    16 Songgang People's Hospital Shenzhen Guangdong China 518105
    17 The Eighth Affiliated Hospital Sun Yat-sen University Shenzhen Guangdong China 528406
    18 Zhuhai People's Hospital Zhuhai Guangdong China 519099
    19 Liuzhou peopleˊs Hospital Liuzhou Guangxi China 545026
    20 The Second Nanning People's Hospital Nanning Guangxi China 530031
    21 The First Affiliated Hospital of Hainan Medical University Haikou Hainan China 570102
    22 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
    23 People's Hospital of zhengzhou Zhengzhou Henan China 450053
    24 Henan Provincial People's Hospital Zhenzhou Henan China 450003
    25 Tongji Medical College of HUST Wuhan Hubei China 215104
    26 The Central Hospital of Wuhan Wuhan Hubei China 430014
    27 The Third Xiangya Hospital of Central South University Changsha Hunan China 410013
    28 Jiangsu Provincial Hospital of Chinese Medicine Nanjing Jiangsu China 210004
    29 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008
    30 The Second Affiliated Hospital of Soochow University Suzhou Jiangsu China 215004
    31 The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China 221004
    32 Nanchang reproductive hospital Nanchang Jiangxi China 330001
    33 First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    34 The Affiliated Hospital to Changchun University of Traditional Medicine Changchun Jilin China 130021
    35 The Frist Hospital of Jilin University Changchun Jilin China 130061
    36 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
    37 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750003
    38 Qinghai university affiliated hospital Xining Qinghai China 810012
    39 Shandong Provincial Hospital Jinan Shandong China 250021
    40 Tongji Hospital of Tongji University Shanghai Shanghai China 200065
    41 Shanghai Ceneral Hospital Shanghai Shanghai China 200940
    42 Shanghai Pudong Hospital ,Fudan university PuDong Medical center Shanghai Shanghai China 201399
    43 First Hospital of Shanxi Medical University Taiyuan Shanxi China 030001
    44 Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital Chengdou Sichuan China 610072
    45 Clinical Medical College & Affiliated Hospital of Chengdu University Chengdou Sichuan China 610081
    46 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China 310014
    47 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325015

    Sponsors and Collaborators

    • Vigonvita Life Sciences

    Investigators

    • Principal Investigator: Hui Jiang, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vigonvita Life Sciences
    ClinicalTrials.gov Identifier:
    NCT05188989
    Other Study ID Numbers:
    • TPN171H-E301
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Jan 21, 2022