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