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A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia (COMORBID©)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00855582
First received: March 3, 2009
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
Results First Received: June 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Erectile Dysfunction
Benign Prostatic Hyperplasia
Interventions: Drug: Tadalafil
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There is a 4-week washout during Screening in order to assess symptoms and uroflowmetry data in the absence of therapy. After the screening/washout period, subjects began a 4-week single-blind, placebo lead-in period to assess treatment and study procedure compliance and to establish baseline levels.

Reporting Groups
  Description
Tadalafil 2.5 mg 2.5 mg tablet once daily by mouth for 12 weeks.
Tadalafil 5 mg 5 mg tablet once daily by mouth for 12 weeks.
Placebo Matching placebo tablet once daily by mouth for 12 weeks.

Participant Flow:   Overall Study
    Tadalafil 2.5 mg     Tadalafil 5 mg     Placebo  
STARTED     198     208     200  
COMPLETED     172     184     170  
NOT COMPLETED     26     24     30  
Adverse Event                 2                 6                 3  
Death                 1                 0                 0  
Lack of Efficacy                 1                 3                 8  
Lost to Follow-up                 1                 3                 1  
Physician Decision                 0                 0                 1  
Protocol Violation                 6                 2                 6  
Entry Criteria Not Met                 8                 6                 3  
Withdrawal by Subject                 7                 4                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Tadalafil 2.5 mg 2.5 mg tablet once daily by mouth for 12 weeks.
Tadalafil 5 mg 5 mg tablet once daily by mouth for 12 weeks.
Placebo Matching placebo tablet once daily by mouth for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Tadalafil 2.5 mg     Tadalafil 5 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  198     208     200     606  
Age  
[units: years]
Mean ± Standard Deviation 		  62.2  ± 7.56     62.5  ± 8.43     62.9  ± 8.23     62.6  ± 8.08  
Gender  
[units: participants]
 		       
Female     0     0     0     0  
Male     198     208     200     606  
Ethnicity (NIH/OMB)  
[units: participants]
 		       
Hispanic or Latino     33     31     30     94  
Not Hispanic or Latino     165     177     170     512  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		       
American Indian or Alaska Native     1     0     0     1  
Asian     6     6     2     14  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     9     6     8     23  
White     181     194     190     565  
More than one race     1     2     0     3  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
France     17     24     21     62  
Portugal     8     3     6     17  
United States     71     71     68     210  
Mexico     27     27     22     76  
Canada     22     23     26     71  
Greece     7     9     9     25  
Russian Federation     21     29     25     75  
Germany     10     12     9     31  
Italy     15     10     14     39  
Body Mass Index (BMI) [1]
[units: kg/m²]
Mean ± Standard Deviation 		  27.7  ± 3.86     28.0  ± 4.18     28.6  ± 4.8     28.1  ± 4.3  
Lower Urinary Tract Symptoms (LUTS) Severity [2]
[units: participants]
 		       
Moderate (IPSS <20)     123     124     122     369  
Severe (IPSS ≥20)     74     84     78     236  
Unknown     1     0     0     1  
Peak Urine Flow Rate (Qmax)  
[units: participants]
 		       
<10 mL/sec     96     87     99     282  
10-15 mL/sec     73     83     66     222  
>15mL/sec     21     16     16     53  
Unknown     8     22     19     49  
Postvoid Residual Volume (PRV)  
[units: mL]
Mean ± Standard Deviation 		  53.0  ± 51.24     51.1  ± 60.91     55.5  ± 60.46     53.2  ± 57.72  
Erectile Dysfunction (ED) - Etiology  
[units: participants]
 		       
Psychogenic     13     15     12     40  
Organic     65     70     85     220  
Mixed     76     83     63     222  
Unknown     44     40     40     124  
ED - Severity [3]
[units: participants]
 		       
Mild (IIEF EF Domain 17-30)     104     99     93     296  
Moderate (IIEF EF Domain 11-16)     46     54     49     149  
Severe (IIEF EF Domain 1-10)     48     55     58     161  
ED - Duration  
[units: participants]
 		       
<1 year     12     20     19     51  
≥1 year     186     188     181     555  
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
[2] The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
[3] 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; lower numerical scores represent greater severity of erectile dysfunction.



  Outcome Measures
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1.  Primary:   Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 2

3.  Primary:   Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 3

4.  Primary:   Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
Measure Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
Time Frame Baseline, 12 weeks  
Safety Issue No  

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.
Participants with non-missing baseline value and at least one non-missing post baseline value.

Reporting Groups
  Description
Tadalafil 2.5 mg Tablet once daily by mouth for 12 weeks.
Placebo Matching placebo tablet once daily by mouth for 12 weeks.

Measured Values
    Tadalafil 2.5 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  185     187  
Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)  
[units: percentage of yes responses]
Least Squares Mean ± Standard Error 		  24.6  ± 2.11     12.0  ± 2.14  


Statistical Analysis 1 for Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.001
Mean Difference (Final Values) [4] 12.5
Standard Error of the mean ± 2.85
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.
[4] Other relevant estimation information:
  No text entered.



8.  Secondary:   Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint   [ Time Frame: Baseline, 2 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint   [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint   [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint   [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint   [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 20

21.  Secondary:   Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 22

23.  Secondary:   Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 24

25.  Secondary:   Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint   [ Time Frame: 12 weeks ]
  Show Outcome Measure 25

26.  Secondary:   Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint   [ Time Frame: 12 weeks ]
  Show Outcome Measure 26

27.  Secondary:   Erectile Function General Assessment Questionnaire (EF-GAQ)   [ Time Frame: 12 weeks ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 28

29.  Secondary:   Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 30


  Serious Adverse Events
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  Other Adverse Events
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  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 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
P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.  


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00855582     History of Changes
Other Study ID Numbers: 11667, H6D-MC-LVHR
Study First Received: March 3, 2009
Results First Received: June 1, 2011
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration