Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Phase 3 Study to Evaluate Longterm 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

NCT01901640

Enrollment

302

Registered

2013-07-17

Start date

2011-11-30

Completion date

2012-11-30

Last updated

2013-07-17

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

Conditions

Erectile Dysfunction

Brief summary

Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159\_EDD\_III)

Detailed description

Completer from parent study(DA8159\_EDD\_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

Interventions

DRUGDA-8159 (Udenafil)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male patients aged 20 years or more diagnosed with erectile dysfunction(ED)

Exclusion criteria

* Had uncontrolled blood pressure * Had hepatic or renal dysfunction * Had significant psychiatric disorders or drug abuses * Was currently under anticancer chemotherapy * Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors

Design outcomes

Primary

Measure	Time frame	Description
Safety	48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)	Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.

Secondary

Measure	Time frame	Description
International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal	48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)	The efficacy measures(Unit of Measure) * IIEF EF domain score(Change from baseline) * IIEF other domain scores(Change from baseline) * GAQ & Shift to normal(percentage of subject)

Outcome results

None listed

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