Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.

Erectile Dysfunction Clinical Trial

Official title:

A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of TPN171H in Patients With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188989
• Other study ID #: TPN171H-E301
• Status: Completed
• Phase: Phase 3
• Start date: December 31, 2021
• Est. completion date: February 14, 2023

Study information

• Verified date: March 2023
• Source: Vigonvita Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Xiyuan Hospital china Academy of chinese Medical Sciences	Beijing	Beijing
China	The Affiliated Hospital to Changchun University of Traditional Medicine	Changchun	Jilin
China	The Frist Hospital of Jilin University	Changchun	Jilin
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Clinical Medical College & Affiliated Hospital of Chengdu University	Chengdou	Sichuan
China	Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital	Chengdou	Sichuan
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
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	The First Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	Shandong Provincial Hospital	Jinan	Shandong
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Liuzhou people´s Hospital	Liuzhou	Guangxi
China	First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanchang reproductive hospital	Nanchang	Jiangxi
China	Jiangsu Provincial Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	The Second Nanning People's Hospital	Nanning	Guangxi
China	Shanghai Ceneral Hospital	Shanghai	Shanghai
China	Shanghai Pudong Hospital ,Fudan university PuDong Medical center	Shanghai	Shanghai
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
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	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Tongji Medical College of HUST	Wuhan	Hubei
China	The first affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Qinghai university affiliated hospital	Xining	Qinghai
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	People's Hospital of zhengzhou	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhenzhou	Henan
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Vigonvita Life Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 4?8	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 ,4 weeks and 8 weeks
Secondary	Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) =26 at Week 4?8?12	Assessed was the changes in the number of subjects whose IIEF domain score at the 8th week visit was =26.	baseline , 4 weeks , 8 weeks ,12 weeks
Secondary	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	Self-reported ,Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction over the past 12 weeks.	baseline , 4 weeks , 8 weeks ,12 weeks
Secondary	Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 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 , 4 weeks , 8 weeks
Secondary	Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 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 , 4 weeks , 8 weeks