Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Dong-A Pharmaceutical Co., Ltd.349 enrolled

Overview

Study Design : multi-center, double-blind, placebo-controlled, randomized, parallel group, fixed dose design Phase : Phase III

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

349

Conditions

Erectile Dysfunction

Interventions

DA-8159 (Udenafil)DRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patients aged 20 years or more diagnosed with ED Exclusion Criteria: * Had uncontrolled blood pressure * Had hepatic or renal dysfunction * Was currently under anticancer chemotherapy * Had a treatments for ED using other PDE-5 inhibitors

Outcomes

Primary Outcomes

IIEF EF domain score

Time frame: 24 weeks

Secondary Outcomes

IIEF, IPSS

Time frame: 24 weeks

Data from ClinicalTrials.gov

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