Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

Erectile Dysfunction Clinical Trial

Official title:

A Multicenter, Open Study to Evaluate the Long-term Safety and Efficacy of TPN171H in Patients With Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301854
• Other study ID #: TPN171H-E302
• Status: Recruiting
• Phase: Phase 3
• Start date: April 12, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Vigonvita Life Sciences
• Contact: Huaqing Duan
• Phone: +86-18061926005
• Email: huaqing.duan[@]vigonvita.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years to 75 years (inclusive);
• Males with ED at least 3 months;
• IIEF-5 = 21 at visit 1;
• Patients in a stable, heterosexual relationship during the study;
• 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 are willing to have 4 or more attempts of sexual intercourse per month, 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 last dose;
• 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 do not respond to marketed PDE5 inhibitors or have adverse reactions that lead to drug discontinuation;
• CYP3A4 potent inhibitors, moderate inhibitors, and potent inducers need to be used during the trial or discontinued for less than 31 days before enrollment;
• Subjects who are taking nitrate or NO donor drugs, guanylate cyclase agonists and cannot be discontinued during the trial;
• 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) or uncontrolled hypertension (=180/110mmHg);
• Patients with diabetic complications (diabetic nephropathy, peripheral neuropathy);
• Patients with hepatic or renal dysfunction as per the following: AST, ALT>3*ULN, serum creatinine exceeds 50% 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 who are unable or unwilling to cooperate;
• Patients whose partner is breastfeeding/pregnant/trying to become pregnant, has a gynecological disease or is restricted in their activities during treatment;
• Patients who have used other drugs in clinical trials within the last 1 month;
• For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• TPN171H
10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine	Changsha	Hunan
China	Nuclear Industry 416 Hospital	Chengdu	Sichuang
China	The Affiliated Hospital of Chengdu University	Chengdu	Sichuang
China	Chifeng Municipal Hospital	Chifeng	Neimenggu
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The 2nd Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Loudi Central Hospital	Loudi	Hunan
China	Nanchang reproductive hospital	Nanchang	Jiangxi
China	Qingyuan People's Hospital	Qingyuan	G
China	Shantou Central Hospital	Shantou	Guangdong
China	The Second Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Shenzhen Songgang People's Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical Uniyersity	Shijiazhuang	Hebei
China	Suining Central Hospital	Suining	Sichuang
China	Second Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine	Urumqi	Xinjiang
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	The Second Affiliated Hospital of Shaanxi University of Chinese Medicine	Xian	Shanxi
China	Xianyang Central Hospital	Xianyang	Shanxi
China	Xingtai People's Hospital	Xingtai	Hebei
China	The Affiliated Hospital of Qinghai University	Xining	Qinghai
China	Yichang Central People's Hospital (Xiling Campus)	Yichang	Jiangxi
China	Yueyang People's Hospital	Yueyang	Hunan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Henan University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Vigonvita Life Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation.	Adverse events occurring throughout the study period were assessed and graded.	during the treatment and observation.
Secondary	Change From Baseline in the International Index of Erectile Function - Erectile Function.	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,3 months, 6 months
Secondary	Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month 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,3 months, 6 months
Secondary	Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responsesat 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,3 months, 6 months
Secondary	Percentage of subjects whose IIEF-EF scores returned to normal (=26) at the 3rd and 6th month of medication.	Assessed was the changes in the number of subjects whose IIEF domain score at the 6th month visit was =26.	baseline,3 months, 6 months
Secondary	Change From Baseline to the 3rd months and 6th months 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.	baseline,3 months, 6 months
Secondary	Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month.	Percentage of respondents who answered "yes" to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of "yes" answers per participant.	3 months, 6 months
Secondary	Change From Baseline in the International Index of Erectile Function - Erectile Function.	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,3 months, 6 months, 9 months and 12 months
Secondary	Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd,6th,9th,12th month 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,3 months, 6 months, 9 months and 12 months
Secondary	Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd,6th,9th,12th month in Percentage of Yes Responsesat 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,3 months, 6 months, 9 months and 12 months
Secondary	Percentage of subjects whose IIEF-EF scores returned to normal (=26) at the the 3rd,6th,9th,12th month of medication.	Assessed was the changes in the number of subjects whose IIEF domain score at the 3rd,6th,9th,12th month visit was =26.	baseline,3 months, 6 months, 9 months and 12 months
Secondary	Change From Baseline to the 3rd,6th,9th,12th month 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.	baseline, 3 months, 6 months, 9 months and 12 months
Secondary	Percentage of respondents who answered "yes" to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd,6th,9th,12th month .	Percentage of respondents who answered "yes" to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of "yes" answers per participant.	3 months, 6 months, 9 months and 12 months