Text Size

Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00422734
First received: January 16, 2007
Last updated: June 8, 2009
Last verified: June 2009
History of Changes
Results First Received: December 23, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Impotence
Interventions: Drug: tadalafil
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Placebo Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil 5 mg tadalafil tablet taken by mouth once a day for 12 weeks

Participant Flow:   Overall Study
    Placebo     Tadalafil  
STARTED     78     264  
COMPLETED     64     243  
NOT COMPLETED     14     21  
Physician Decision                 1                 1  
Protocol Violation                 1                 6  
Withdrawal by Subject                 12                 8  
Adverse Event                 0                 3  
Partner Decision                 0                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo Placebo tablet taken by mouth once a day for 12 weeks
Tadalafil 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Tadalafil     Total  
Number of Participants  
[units: participants]
 		  78     264     342  
Age  
[units: years]
Mean ± Standard Deviation 		  53.82  ± 10.72     54.42  ± 10.04     54.29  ± 10.18  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     78     264     342  
Region of Enrollment  
[units: participants]
 		     
France     11     41     52  
United States     29     107     136  
Mexico     19     63     82  
Austria     8     17     25  
Germany     11     36     47  
Erectile Dysfunction History - Duration  
[units: participants]
 		     
>= 1 year     73     240     313  
>= 3 months and < 6 months     1     8     9  
>= 6 months and < 1 year     4     16     20  
Erectile Dysfunction History - Etiology  
[units: participants]
 		     
Mixed     34     114     148  
Organic     29     91     120  
Psychogenic     12     30     42  
Unknown     3     29     32  
International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity  
[units: participants]
 		     
Mild (17-30)     35     123     158  
Moderate (11-16)     22     71     93  
Severe (1-10)     20     63     83  
Missing     1     7     8  
Race/Ethnicity  
[units: participants]
 		     
African     0     6     6  
Caucasian     57     188     245  
Hispanic     21     69     90  
Native American     0     1     1  
International Index of Erectile Function (IIEF) - Erectile Function Domain [1]
[units: units on a scale]
Mean ± Standard Deviation 		  15.27  ± 6.49     15.73  ± 6.13     15.62  ± 6.21  
[1] Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 1

2.  Primary:   Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 2

3.  Primary:   Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain   [ Time Frame: 12 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response   [ Time Frame: 12 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response   [ Time Frame: 12 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 14


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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 less than or equal to 60 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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00422734     History of Changes
Other Study ID Numbers: 9501, H6D-MC-LVGH
Study First Received: January 16, 2007
Results First Received: December 23, 2008
Last Updated: June 8, 2009
Health Authority: United States: Food and Drug Administration