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This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial design.
This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial design. The pharmacodynamic effects of different doses of TPN171H tablets on mild to moderate male patients with erectile dysfunction were evaluated by penile plethysmography (RigiScan PlusTM technique) using audiovisual sexual stimulation (AVSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | N=14 subjects receive 2.5 mg TPN171H and 10 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2 ; 10 mg Placebo and 5 mg Placebo for Period 3. |
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| Sequence 2 | Experimental | N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2 ; 2.5 mg TPN171H and 10 mg Placebo for Period 3. |
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| Sequence 3 | Experimental | N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 2.5 mg TPN171H and 10 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3. |
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| Sequence 4 | Experimental | N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg TPN171H and 5 mg Placebo for Period 2; 10 mg Placebo and 5 mg Placebo for Period 3. |
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| Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPN171H 2.5mg | Drug | TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM). | Baseline and during audiovisual sexual stimulation(60minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| The starting time of penile erections of greater than or equal to 60% rigidity | Baseline and during audiovisual sexual stimulation(60minutes) | |
| Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM). |
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Inclusion Criteria:
Exclusion Criteria:
Myocardial infarction or shock, or life-threatening arrhythmia within the last 6 months; Unstable angina or angina occurring during sexual intercourse within the last 3 months; Received coronary artery bypass grafting or percutaneous coronary intervention within the last 3 months;New York Heart Association Class 2 or greater heart failure in the last 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Hui Jiang | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China | ||
| Peking University Third Hospital |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Experimental |
N=14 subjects receive 10 mg TPN171H and 5 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3. |
|
| Sequence 6 | Experimental | N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2; 10 mg TPN171H and 5 mg Placebo for Period 3. |
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| TPN171H 5mg | Drug | TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) |
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| TPN171H 10mg | Drug | TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) |
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| Placebo 5mg | Drug | Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) |
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| Placebo 10mg | Drug | Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner) |
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| Baseline and during audiovisual sexual stimulation(minutes) |
| Percentage increase in penile enlargement | Baseline and during audiovisual sexual stimulation(60minutes) |
| The incidence of penile erection rigidity grade ≥ grade III. | Baseline and during audiovisual sexual stimulation(60minutes) |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 35004 | China |
| Henan Provincial People's Hospital | Zhenzhou | Henan | 450003 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The First Hospital of Jilin University | Changchun | Jinlin | 130021 | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |