Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.
A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of TPN171H in Patients With Erectile Dysfunction
1 other identifier
interventional
765
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2021
Shorter than P25 for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2021
CompletedStudy Start
First participant enrolled
December 31, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2023
CompletedMarch 7, 2023
March 1, 2023
1.1 years
December 29, 2021
March 6, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 .
baseline and 12 weeks
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.
baseline and 12 weeks
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.
baseline and 12 weeks
Secondary Outcomes (5)
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
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
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
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
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses
baseline , 4 weeks , 8 weeks
Study Arms (4)
TPN171H 2.5mg group
EXPERIMENTALTPN171H 5mg group
EXPERIMENTALTPN171H 10mg group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
The Second People's Hospital of Hefei
Hefei, Anhui, 230012, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
The first affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241004, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100000, China
Xiyuan Hospital china Academy of chinese Medical Sciences
Beijing, Beijing Municipality, 100000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 35004, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510700, China
Shenzhen University General Hospital
Shenzhen, Guangdong, 518071, China
Songgang People's Hospital
Shenzhen, Guangdong, 518105, China
The Eighth Affiliated Hospital Sun Yat-sen University
Shenzhen, Guangdong, 528406, China
Zhuhai People's Hospital
Zhuhai, Guangdong, 519099, China
Liuzhou peopleˊs Hospital
Liuchow, Guangxi, 545026, China
The Second Nanning People's Hospital
Nanning, Guangxi, 530031, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
People's Hospital of zhengzhou
Zhengzhou, Henan, 450053, China
Henan Provincial People's Hospital
Zhenzhou, Henan, 450003, China
Tongji Medical College of HUST
Wuhan, Hubei, 215104, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430014, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu, 210004, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
Nanchang reproductive hospital
Nanchang, Jiangxi, 330001, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Affiliated Hospital to Changchun University of Traditional Medicine
Changchun, Jilin, 130021, China
The Frist Hospital of Jilin University
Changchun, Jilin, 130061, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003, China
Qinghai university affiliated hospital
Xining, Qinghai, 810012, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Shanghai Ceneral Hospital
Shanghai, Shanghai Municipality, 200940, China
Shanghai Pudong Hospital ,Fudan university PuDong Medical center
Shanghai, Shanghai Municipality, 201399, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
Chengdou, Sichuan, 610072, China
Clinical Medical College & Affiliated Hospital of Chengdu University
Chengdou, Sichuan, 610081, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325015, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Jiang
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2021
First Posted
January 12, 2022
Study Start
December 31, 2021
Primary Completion
February 14, 2023
Study Completion
February 14, 2023
Last Updated
March 7, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share