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Treatment of Erectile Dysfunction II

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01037218
First received: October 19, 2009
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: July 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Erectile Dysfunction
Interventions: Drug: Udenafil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Subject enrolled 28-Sep-2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Udenafil 50 mg Udenafil 50 mg tablets
Udenafil 100 mg Udenafil 100 mg tablets
Udenafil 150mg Udenafil 150mg tablets
Placebo Placebo tablets

Participant Flow:   Overall Study
    Udenafil 50 mg   Udenafil 100 mg   Udenafil 150mg   Placebo
STARTED   147   149   155   150 
Safety Population   147   148   154   150 
mITT Population   141   140   147   141 
COMPLETED   131   128   134   134 
NOT COMPLETED   16   21   21   16 
Adverse Event                4                2                2                1 
Lack of Efficacy                0                2                1                5 
Lost to Follow-up                3                5                4                2 
Withdrawal by Subject                6                7                7                4 
Partner Withdrew Consent                0                3                2                1 
Protocol Violation                0                0                2                2 
Various                3                2                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects Randomized/Enrolled; Age, Ethnic, Race only available for Safety Population

Reporting Groups
  Description
Udenafil 50 mg Udenafil 50 mg tablets
Udenafil 100 mg Udenafil 100 mg tablets
Udenafil 150mg Udenafil 150mg tablets
Placebo Placebo tablets
Total Total of all reporting groups

Baseline Measures
   Udenafil 50 mg   Udenafil 100 mg   Udenafil 150mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   149   155   150   601 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 59.1  (8.92)   56.8  (10.22)   58.7  (9.48)   58.9  (10.31)   58.4  (9.77) 
[1] Safety Population
Gender 
[Units: Participants]
         
Female   0   0   0   0   0 
Male   147   149   155   150   601 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
         
Hispanic or Latino   7   5   9   8   29 
Not Hispanic or Latino   140   143   145   142   570 
Unknown or Not Reported   0   0   0   0   0 
[1] Race Safety Population
Race (NIH/OMB) [1] 
[Units: Participants]
         
American Indian or Alaska Native   1   2   1   0   4 
Asian   0   1   1   1   3 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   17   20   13   19   69 
White   129   125   139   127   520 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   0   0   3   3 
[1] Safety Population
Region of Enrollment 
[Units: Participants]
         
United States   147   149   155   150   601 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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)   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT   [ Time Frame: Baseline and Weeks 1-12 ]

3.  Primary:   Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT   [ Time Frame: Baseline and Weeks 1-12 ]

4.  Secondary:   Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF   [ Time Frame: Baseline and Week 12 ]

8.  Secondary:   Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population   [ Time Frame: Week 12 ]

9.  Secondary:   Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT   [ Time Frame: Baseline and Week 12 ]

10.  Secondary:   Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT   [ Time Frame: Baseline and Weeks 1-12 ]

12.  Secondary:   Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT   [ Time Frame: Baseline and Weeks 1-12 ]

13.  Secondary:   Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT   [ Time Frame: Baseline and Weeks 1-12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com



Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01037218     History of Changes
Other Study ID Numbers: PR-01309
Study First Received: October 19, 2009
Results First Received: July 12, 2011
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration