Brief Summary

Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,027

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach

1 country

72 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

January 1, 2010

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed

Last Updated

April 20, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

February 5, 2010

Last Update Submit

March 30, 2015

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

International Index of Erectile Function (IIEF) score
Assessment will be made after each use of the study drug over a 36 week use period.

Secondary Outcomes (1)

Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction
Assessment will be made after each use of the study drug over a 36 week use period.

Study Arms (4)

Udenafil 50 mg

EXPERIMENTAL

50 mg Udenafil

Drug: Udenafil 50 mgDrug: Placebo Matching 100 mg UdenafilDrug: Placebo Matching 150 mg Udenafil

Udenafil 100 mg

EXPERIMENTAL

100 mg Udenafil

Drug: Udenafil 100 mgDrug: Placebo Matching 50 mg UdenafilDrug: Placebo Matching 150 mg Udenafil

Udenafil 150 mg

EXPERIMENTAL

150 mg Udenafil

Drug: Udenafil 150 mgDrug: Placebo Matching 50 mg UdenafilDrug: Placebo Matching 100 mg Udenafil

Placebo

PLACEBO COMPARATOR

Placebo Tablets matching Udenafil tablets

Drug: Placebo Matching 50 mg UdenafilDrug: Placebo Matching 100 mg UdenafilDrug: Placebo Matching 150 mg Udenafil

Interventions

Udenafil 50 mgDRUG

Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Also known as: WC3043

Udenafil 50 mg

Udenafil 100 mgDRUG

Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Also known as: WC3043

Udenafil 100 mg

Udenafil 150 mgDRUG

Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Also known as: WC3043

Udenafil 150 mg

Placebo Matching 50 mg UdenafilDRUG

Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Also known as: Placebo 50 mg

PlaceboUdenafil 100 mgUdenafil 150 mg

Placebo Matching 100 mg UdenafilDRUG

Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Also known as: Placebo 100 mg

PlaceboUdenafil 150 mgUdenafil 50 mg

Placebo Matching 150 mg UdenafilDRUG

Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Also known as: Placebo 150 mg

PlaceboUdenafil 100 mgUdenafil 50 mg

Eligibility Criteria

Age19 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject has completed Study PR-01209 or PR-01309
Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
Partner is not pregnant or lactating

You may not qualify if:

Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
Cardiac arrhythmias requiring antiarrhythmic treatment
Symptomatic congestive heart failure
Taking nitrate medication in any form
Uncontrolled diabetes (HbA1c ≥ 13%)
Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors

Contact the study team to confirm eligibility.