Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.

NCT05188989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765

Last updated 2023-03-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TPN171H 2.5mg group

TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse

DRUG

TPN171H 5mg group

TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse

DRUG

TPN171H 10mg group

TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse

DRUG

Placebo group

Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Hui Jiang · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-02-14
Completion
2023-02-14

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188989 on ClinicalTrials.gov