protocolSection identificationModule nctId: NCT06301854, orgStudyIdInfo id: TPN171H-E302, briefTitle: Long-term Safety of TPN171H Tablet in Erectile Dysfunction., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vigonvita Life Sciences, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction., conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: TPN171H, outcomesModule primaryOutcomes measure: Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation., secondaryOutcomes measure: Change From Baseline in the International Index of Erectile Function - Erectile Function., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Change From Baseline in the International Index of Erectile Function - Erectile Function., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication., secondaryOutcomes 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., secondaryOutcomes 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 ., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Anhui Medical University, status: RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Xiansheng Zhang, role: CONTACT, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Peking University First Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100032, country: China, contacts name: Hui Jiang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Kai Hong, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Guangzhou First People's Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Junhong Deng, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Fifth Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510700, country: China, contacts name: Xianhan Jiang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Geng An, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shantou Central Hospital, status: RECRUITING, city: Shantou, state: Guangdong, country: China, contacts name: hong huang, role: CONTACT, geoPoint lat: 23.36814, lon: 116.71479, locations facility: The Second Affiliated Hospital of Shantou University Medical College, status: RECRUITING, city: Shantou, state: Guangdong, country: China, contacts name: Junhong Zheng, role: CONTACT, geoPoint lat: 23.36814, lon: 116.71479, locations facility: Shenzhen Songgang People's Hospital, status: RECRUITING, city: Shenzhen, state: Guangdong, zip: 518105, country: China, contacts name: Qin Xiang, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The 2nd Affiliated Hospital of Guilin Medical University, status: RECRUITING, city: Guilin, state: Guangxi, country: China, contacts name: Li Gao, role: CONTACT, geoPoint lat: 25.28194, lon: 110.28639, locations facility: The Affiliated Hospital of Guizhou Medical University, status: RECRUITING, city: Guiyang, state: Guizhou, country: China, contacts name: Qiang Wang, role: CONTACT, geoPoint lat: 26.58333, lon: 106.71667, locations facility: Qingyuan People's Hospital, status: RECRUITING, city: Qingyuan, state: G, country: China, contacts name: Jianwen Zeng, role: CONTACT, geoPoint lat: 23.7, lon: 113.03333, locations facility: The Second Hospital of Hebei Medical Uniyersity, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, contacts name: Yaxuan Wang, role: CONTACT, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Xingtai People's Hospital, status: RECRUITING, city: Xingtai, state: Hebei, country: China, contacts name: Junli Wei, role: CONTACT, geoPoint lat: 37.06306, lon: 114.49417, locations facility: Henan Provincial People's Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450100, country: China, contacts name: Xiangsheng Zhang, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The First Affiliated Hospital of Henan University, status: RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Guoliang Xu, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Central Hospital of Wuhan, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430014, country: China, contacts name: Yonglian Guo, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Union Hospital, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Zhaohui Zhu, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Yifeng Yuan, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Loudi Central Hospital, status: RECRUITING, city: Loudi, state: Hunan, country: China, contacts name: Liang Peng, role: CONTACT, geoPoint lat: 27.73444, lon: 111.99444, locations facility: Yueyang People's Hospital, status: RECRUITING, city: Yueyang, state: Hunan, country: China, contacts name: Zeping Li, role: CONTACT, geoPoint lat: 29.37455, lon: 113.09481, locations facility: Second Affiliated Hospital of Suzhou University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Boxin Xue, role: CONTACT, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Nanchang reproductive hospital, status: RECRUITING, city: Nanchang, state: Jiangxi, zip: 330001, country: China, contacts name: Wenliang Yao, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Yichang Central People's Hospital (Xiling Campus), status: RECRUITING, city: Yichang, state: Jiangxi, country: China, contacts name: Junfeng Yu, role: CONTACT, geoPoint lat: 30.71444, lon: 111.28472, locations facility: The First Hospital of Jilin University, status: NOT_YET_RECRUITING, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Fubiao Li, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: The Second Hospital of Dalian Medical University, status: NOT_YET_RECRUITING, city: Dalian, state: Liaoning, zip: 116011, country: China, contacts name: Tao Jiang, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Chifeng Municipal Hospital, status: RECRUITING, city: Chifeng, state: Neimenggu, country: China, contacts name: Xin Chen, role: CONTACT, geoPoint lat: 42.26833, lon: 118.96361, locations facility: The Affiliated Hospital of Qinghai University, status: RECRUITING, city: Xining, state: Qinghai, country: China, contacts name: Guoliang Chen, role: CONTACT, geoPoint lat: 36.62554, lon: 101.75739, locations facility: Xianyang Central Hospital, status: RECRUITING, city: Xianyang, state: Shanxi, country: China, contacts name: Nan Li, role: CONTACT, geoPoint lat: 34.33778, lon: 108.70261, locations facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, status: RECRUITING, city: Xian, state: Shanxi, country: China, contacts name: Wei Zheng, role: CONTACT, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Nuclear Industry 416 Hospital, status: RECRUITING, city: Chengdu, state: Sichuang, country: China, contacts name: Jichun Shao, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Affiliated Hospital of Chengdu University, status: RECRUITING, city: Chengdu, state: Sichuang, country: China, contacts name: Jin Yang, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Suining Central Hospital, status: RECRUITING, city: Suining, state: Sichuang, country: China, contacts name: Yougang Feng, role: CONTACT, geoPoint lat: 30.50802, lon: 105.57332, locations facility: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Urumqi, state: Xinjiang, country: China, contacts name: Feng Wang, role: CONTACT, geoPoint lat: 43.80096, lon: 87.60046, hasResults: False