Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01774864

Enrollment

349

Registered

2013-01-24

Start date

2011-04-30

Completion date

2012-05-31

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Brief summary

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

Interventions

DRUGDA-8159 (Udenafil)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
IIEF EF domain score	24 weeks

Secondary

Measure	Time frame
IIEF, IPSS	24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026