Brief Summary

Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo 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

618

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2009

Shorter than P25 for phase_3

Geographic Reach

1 country

36 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

6 months study duration

Study Start

First participant enrolled

September 1, 2009

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2009

Completed

2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2009

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

December 22, 2011

Completed

Last Updated

December 22, 2011

Status Verified

December 1, 2011

Enrollment Period

6 months

First QC Date

October 19, 2009

Results QC Date

July 12, 2011

Last Update Submit

December 21, 2011

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)
Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \& keep your erection?
Baseline and Week 12
Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Baseline and Weeks 1 - 12
Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Baseline and Weeks 1 - 12

Secondary Outcomes (10)

Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
Week 12
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
Baseline to Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
Baseline to Week 12
Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Baseline and Week 12
Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Baseline and Week 12
+5 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Udenafil 50 mg

EXPERIMENTAL

Drug: Udenafil

Udenafil 100 mg

EXPERIMENTAL

Drug: Udenafil

Udenafil 150 mg

EXPERIMENTAL

Drug: Udenafil

Interventions

UdenafilDRUG

Tablets via oral administration before an attempt at sexual intercourse.

Udenafil 100 mgUdenafil 150 mgUdenafil 50 mg

PlaceboDRUG

Tablets via oral administration before an attempt at sexual intercourse.

Placebo

Eligibility Criteria

Age19 Years+

Sexmale

Healthy VolunteersNo

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

You may qualify if:

Male, at least 19 years of age
Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity
History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration
Partner is not pregnant or lactating

You may not qualify if:

History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months
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 such as Viagra®, Cialis® or Levitra®
Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®

Contact the study team to confirm eligibility.