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

601

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2009

Shorter than P25 for phase_3

Geographic Reach

1 country

40 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

7 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

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

December 22, 2011

Completed

Last Updated

June 19, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

October 19, 2009

Results QC Date

July 12, 2011

Last Update Submit

May 20, 2015

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 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? 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
Changes 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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Baseline and Weeks 1-12
Changes in Sexual Encounter Profile (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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Baseline and Weeks 1-12

Secondary Outcomes (10)

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
Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Baseline and Week 12
Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Baseline and Week 12
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
Week 12
+5 more secondary outcomes

Study Arms (4)

Udenafil 50 mg

EXPERIMENTAL

50 mg Udenafil tablet plus 100 \& 150 mg placebo tablets

Drug: UdenafilDrug: Placebo

Udenafil 100 mg

EXPERIMENTAL

100 mg Udenafil tablet plus 50 \& 150 mg placebo tablets

Drug: UdenafilDrug: Placebo

Udenafil 150mg

EXPERIMENTAL

150 mg Udenafil tablet plus 50 \& 100 mg placebo tablets

Drug: UdenafilDrug: Placebo

Placebo

PLACEBO COMPARATOR

50, 100 \& 150 mg placebo tablets

Drug: Placebo

Interventions

UdenafilDRUG

Tablets via oral administration before an attempt at sexual intercourse.

Udenafil 100 mgUdenafil 150mgUdenafil 50 mg

PlaceboDRUG

Tablets via oral administration before an attempt at sexual intercourse.

PlaceboUdenafil 100 mgUdenafil 150mgUdenafil 50 mg

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.