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A Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients

NCT03102398 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-11-22

No results posted yet for this study

Summary

The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion.

Conditions

Interventions

DRUG

TR-399 (5% Vardenafil HCl·3H2O, topical gel)

5% Vardenafil HCl·3H2O, topical gel, 2 drops (50ul, 2.5mg), q.d.

Sponsors & Collaborators

  • A2 Healthcare Taiwan Corporation

    collaborator INDUSTRY

  • Tritech Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2018-01-31
Completion
2018-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT03102398 on ClinicalTrials.gov