NCT04479917

Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction

A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Dose-Exploring Study to Evaluate the Efficacy and Safety of TPN171H in China Male Patients With Erectile Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: Male
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg, 20mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, TPN171H 5mg, 10mg or 20mg 30 minutes to 4 hours before sexual intercourse for 8 weeks.

Detailed description

This is a Phase II study in 240 ED patients, which consists of 3 part: 1) a 4-week run-in period without any ED treatment; 2)randomization to 8 weeks of treatment with TPN171H or placebo; and 3) a 1-week follow-up period for continued adverse event monitoring. The effects of TPN171H on ED will be evaluated using the IIEF-EF and SEP diaries. The IIEF-EF will be administered at baseline and at 4-week intervals following initiation of treatment, meanwhile the SEP diary will be completed by patients after each sexual attempt throughout the study.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	TPN171H	Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
DRUG	placebo	Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Timeline

• Start date: 2020-07-23
• Primary completion: 2021-07-26
• Completion: 2021-07-26
• First posted: 2020-07-21
• Last updated: 2023-06-22

Locations

12 sites across 1 country: China