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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPN171H 2.5mg group | Experimental |
| |
| TPN171H 5mg group | Experimental |
| |
| TPN171H 10mg group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPN171H 2.5mg group | Drug | TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Jiang | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Hefei | Hefei | Anhui | 230012 | China | ||
| The First Affiliated Hospital of Anhui Medical University |
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| TPN171H 5mg group | Drug | TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse |
|
|
| TPN171H 10mg group | Drug | TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse |
|
|
| Placebo group | Drug | Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse |
|
| 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 |
| 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 |
| 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 |
| 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 |
| Hefei |
| Anhui |
| 230022 |
| China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| The first affiliated Hospital of Wannan Medical College | Wuhu | Anhui | 241004 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
| Peking University Shougang Hospital | Beijing | Beijing Municipality | 100000 | China |
| Xiyuan Hospital china Academy of chinese Medical Sciences | Beijing | Beijing Municipality | 100000 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 35004 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | 730030 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510180 | China |
| Southern Medical University Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| The Fifth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510700 | China |
| Shenzhen University General Hospital | Shenzhen | Guangdong | 518071 | China |
| Songgang People's Hospital | Shenzhen | Guangdong | 518105 | China |
| The Eighth Affiliated Hospital Sun Yat-sen University | Shenzhen | Guangdong | 528406 | China |
| Zhuhai People's Hospital | Zhuhai | Guangdong | 519099 | China |
| Liuzhou peopleˊs Hospital | Liuzhou | Guangxi | 545026 | China |
| The Second Nanning People's Hospital | Nanning | Guangxi | 530031 | China |
| The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | 570102 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| People's Hospital of zhengzhou | Zhengzhou | Henan | 450053 | China |
| Henan Provincial People's Hospital | Zhenzhou | Henan | 450003 | China |
| Tongji Medical College of HUST | Wuhan | Hubei | 215104 | China |
| The Central Hospital of Wuhan | Wuhan | Hubei | 430014 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| Jiangsu Provincial Hospital of Chinese Medicine | Nanjing | Jiangsu | 210004 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221004 | China |
| Nanchang reproductive hospital | Nanchang | Jiangxi | 330001 | China |
| First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Affiliated Hospital to Changchun University of Traditional Medicine | Changchun | Jilin | 130021 | China |
| The Frist Hospital of Jilin University | Changchun | Jilin | 130061 | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750003 | China |
| Qinghai university affiliated hospital | Xining | Qinghai | 810012 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Tongji Hospital of Tongji University | Shanghai | Shanghai Municipality | 200065 | China |
| Shanghai Ceneral Hospital | Shanghai | Shanghai Municipality | 200940 | China |
| Shanghai Pudong Hospital ,Fudan university PuDong Medical center | Shanghai | Shanghai Municipality | 201399 | China |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital | Chengdou | Sichuan | 610072 | China |
| Clinical Medical College & Affiliated Hospital of Chengdu University | Chengdou | Sichuan | 610081 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325015 | China |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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