Clinical trial NCT06301854: Long-term Safety of TPN171H Tablet in Erectile Dysfunction.
Official title: A Multicenter, Open Study to Evaluate the Long-term Safety and Efficacy of TPN171H in Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Vigonvita Life Sciences
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 472
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation.
timeFrame: during the treatment and observation.
Secondary outcomes:
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function.
timeFrame: baseline，3 months, 6 months
measure: 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.
timeFrame: baseline，3 months, 6 months
measure: 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.
timeFrame: baseline，3 months, 6 months
measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication.
timeFrame: baseline，3 months, 6 months
measure: 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.
timeFrame: baseline，3 months, 6 months
measure: 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.
timeFrame: 3 months, 6 months
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function.
timeFrame: baseline，3 months, 6 months, 9 months and 12 months
measure: 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.
timeFrame: baseline，3 months, 6 months, 9 months and 12 months
measure: 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.
timeFrame: baseline，3 months, 6 months, 9 months and 12 months
measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication.
timeFrame: baseline，3 months, 6 months, 9 months and 12 months
measure: 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.
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: 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 .
timeFrame: 3 months, 6 months, 9 months and 12 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Songgang People's Hospital
state: Guangdong
city: Guilin
country: China
facility: The 2nd Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Qingyuan
country: China
facility: Qingyuan People's Hospital
state: G
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical Uniyersity
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
city: Yueyang
country: China
facility: Yueyang People's Hospital
state: Hunan
city: Suzhou
country: China
facility: Second Affiliated Hospital of Suzhou University
state: Jiangsu
city: Nanchang
country: China
facility: Nanchang reproductive hospital
state: Jiangxi
city: Yichang
country: China
facility: Yichang Central People's Hospital (Xiling Campus)
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Neimenggu
city: Xining
country: China
facility: The Affiliated Hospital of Qinghai University
state: Qinghai
city: Xianyang
country: China
facility: Xianyang Central Hospital
state: Shanxi
city: Xian
country: China
facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
state: Shanxi
city: Chengdu
country: China
facility: Nuclear Industry 416 Hospital
state: Sichuang
city: Chengdu
country: China
facility: The Affiliated Hospital of Chengdu University
state: Sichuang
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuang
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
state: Xinjiang
Study officials:
affiliation: Peking University First Hospital
name: Hui Jiang
role: PRINCIPAL_INVESTIGATOR
References: