NCT05388825

Pharmacodynamic Study of TPN171H Tablets in Patients With Mild to Moderate Erectile Dysfunction

A Randomized, Double-blind, Placebo-controlled, Two-cohort, Three-way Crossover Clinical Trial to Evaluate the Pharmacodynamic Effect of Different Doses of TPN171H Tablets in Mild to Moderate Male Erectile Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	TPN171H 2.5mg	TPN171H 2.5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
DRUG	TPN171H 5mg	TPN171H 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
DRUG	TPN171H 10mg	TPN171H 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
DRUG	Placebo 5mg	Placebo 5mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)
DRUG	Placebo 10mg	Placebo 10mg is recommended to take warm water on an empty stomach (2 hours or more after dinner)

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-04
• Completion: 2023-02-17
• First posted: 2022-05-24
• Last updated: 2023-02-23

Locations

8 sites across 1 country: China