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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Henan Provincial People's Hospital
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Time frame: Baseline and during audiovisual sexual stimulation(60minutes)
The starting time of penile erections of greater than or equal to 60% rigidity
Time frame: 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).
Time frame: Baseline and during audiovisual sexual stimulation(minutes)
Percentage increase in penile enlargement
Time frame: Baseline and during audiovisual sexual stimulation(60minutes)
The incidence of penile erection rigidity grade ≥ grade III.
Time frame: Baseline and during audiovisual sexual stimulation(60minutes)
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Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
Zhenzhou, Henan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jinlin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China