Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.
NCT ID: NCT05188989
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
765 participants
INTERVENTIONAL
2021-12-31
2023-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TPN171H 2.5mg group
TPN171H 2.5mg group
TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
TPN171H 5mg group
TPN171H 5mg group
TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
TPN171H 10mg group
TPN171H 10mg group
TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Placebo group
Placebo group
Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse
Interventions
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TPN171H 2.5mg group
TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
TPN171H 5mg group
TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
TPN171H 10mg group
TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse
Placebo group
Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
MALE
No
Sponsors
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Vigonvita Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Hui Jiang
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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The Second People's Hospital of Hefei
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The first affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital china Academy of chinese Medical Sciences
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Songgang People's Hospital
Shenzhen, Guangdong, China
The Eighth Affiliated Hospital Sun Yat-sen University
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Liuzhou peopleˊs Hospital
Liuzhou, Guangxi, China
The Second Nanning People's Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
People's Hospital of zhengzhou
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhenzhou, Henan, China
Tongji Medical College of HUST
Wuhan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Nanchang reproductive hospital
Nanchang, Jiangxi, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Affiliated Hospital to Changchun University of Traditional Medicine
Changchun, Jilin, China
The Frist Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai university affiliated hospital
Xining, Qinghai, China
Shandong Provincial Hospital
Jinan, Shandong, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Shanghai Ceneral Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pudong Hospital ,Fudan university PuDong Medical center
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
Chengdou, Sichuan, China
Clinical Medical College & Affiliated Hospital of Chengdu University
Chengdou, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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TPN171H-E301
Identifier Type: -
Identifier Source: org_study_id
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