Clinical trial NCT05188989: Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.
Official title: A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of TPN171H in Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Vigonvita Life Sciences
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 765
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
timeFrame: baseline and 12 weeks
measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
timeFrame: baseline and 12 weeks
measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 4、8
timeFrame: baseline ,4 weeks and 8 weeks
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 4、8、12
timeFrame: baseline , 4 weeks , 8 weeks ,12 weeks
measure: 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
timeFrame: baseline , 4 weeks , 8 weeks ,12 weeks
measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses
timeFrame: baseline , 4 weeks , 8 weeks
measure: Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses
timeFrame: baseline , 4 weeks , 8 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: The first affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital china Academy of chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen University General Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Songgang People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou peopleˊs Hospital
state: Guangxi
city: Nanning
country: China
facility: The Second Nanning People's Hospital
state: Guangxi
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: People's Hospital of zhengzhou
state: Henan
city: Zhenzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Medical College of HUST
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Nanchang reproductive hospital
state: Jiangxi
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The Affiliated Hospital to Changchun University of Traditional Medicine
state: Jilin
city: Changchun
country: China
facility: The Frist Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xining
country: China
facility: Qinghai university affiliated hospital
state: Qinghai
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ceneral Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital ,Fudan university PuDong Medical center
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdou
country: China
facility: Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdou
country: China
facility: Clinical Medical College & Affiliated Hospital of Chengdu University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Peking University Third Hospital
name: Hui Jiang
role: PRINCIPAL_INVESTIGATOR
References: