Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00386009
First received: October 9, 2006
Last updated: July 1, 2009
Last verified: July 2009
Results First Received: May 4, 2009  
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: 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
No text entered.

Reporting Groups
  Description
Placebo placebo tablet taken by mouth once a day for 12 weeks
Tadalafil 20 mg tadalafil tablet taken by mouth once a day for 12 weeks

Participant Flow:   Overall Study
    Placebo     Tadalafil  
STARTED     101     99  
COMPLETED     92     89  
NOT COMPLETED     9     10  
Adverse Event                 0                 2  
Death                 1                 0  
Entry Criteria Not Met                 0                 2  
Lost to Follow-up                 1                 1  
Protocol Violation                 1                 0  
Sponsor Decision                 1                 1  
Withdrawal by Subject                 5                 4  



  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.
No text entered.

Reporting Groups
  Description
Placebo placebo tablet taken by mouth once a day for 12 weeks
Tadalafil 20 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]
  101     99     200  
Age  
[units: years]
Mean ± Standard Deviation
  59.03  ± 9.69     58.16  ± 8.82     58.60  ± 9.26  
Gender  
[units: participants]
     
Female     0     0     0  
Male     101     99     200  
Region of Enrollment  
[units: participants]
     
United States     99     95     194  
Canada     2     4     6  
Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity [1]
[units: participants]
     
Moderate (IPSS <20)     34     35     69  
Severe (IPSS ≥20)     66     62     128  
Missing Baseline Measure     1     2     3  
Bladder Outlet Obstruction Index (BOOI) [2]
[units: participants]
     
Obstructed (BOOI > 40)     33     34     67  
Equivocal (BOOI 20-40)     35     34     69  
Unobstructed (BOOI < 20)     33     31     64  
Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS)  
[units: participants]
     
6 months to 1 year     13     12     25  
1 year to 3 years     36     30     66  
> 3 years     52     57     109  
Erectile Dysfunction Severity [3]
[units: participants]
     
Mild     20     22     42  
Moderate     31     31     62  
Severe     9     5     14  
Presence of Erectile Dysfunction  
[units: participants]
     
Yes     60     58     118  
No     41     41     82  
Previous Alpha-Blocker Therapy  
[units: participants]
     
Yes     22     21     43  
No     79     78     157  
Previous Therapy for Benign Prostatic Hyperplasia  
[units: participants]
     
Yes     34     29     63  
No     67     70     137  
Race/Ethnicity  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     3     2     5  
Black or African American     12     13     25  
Hispanic or Latino     8     8     16  
White     78     75     153  
Body Mass Index (BMI) [4]
[units: kilograms/square centimeters (kg/cm^2)]
Mean ± Standard Deviation
  29.44  ± 4.47     29.45  ± 4.93     29.45  ± 4.69  
Body Weight  
[units: kilograms]
Mean ± Standard Deviation
  92.94  ± 16.55     93.90  ± 16.49     93.42  ± 16.49  
Height  
[units: centimeters]
Mean ± Standard Deviation
  177.56  ± 8.07     178.58  ± 7.50     178.07  ± 7.79  
Postvoid Residual Volume by Ultrasound  
[units: milliliters]
Mean ± Standard Deviation
  59.30  ± 60.87     45.65  ± 49.58     52.51  ± 55.82  
Prostate Specific Antigen (PSA)  
[units: nanograms per milliliter]
Mean ± Standard Deviation
  1.60  ± 1.13     1.51  ± 1.14     1.55  ± 1.13  
[1] Severity was determined by the International Prostate Symptom Score (IPSS)Total. The IPSS is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
[2] BOOI, or bladder outlet obstruction index, which is derived from the equation: pdetQmax-2Qmax (where pdetQmax is detrusor pressure at peak urinary flow rate and Qmax is defined as the peak urine flow rate).
[3] This measure is only for participants who have Erectile Dysfunction.
[4] Body mass index is an estimate of body fat based on body weight divided by height squared.



  Outcome Measures
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1.  Primary:   Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

7.  Secondary:   Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

8.  Secondary:   Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

9.  Secondary:   Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

10.  Secondary:   Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

11.  Secondary:   Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

12.  Secondary:   Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

13.  Secondary:   Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies   [ Time Frame: Baseline and 12 weeks ]

14.  Secondary:   Presence of Involuntary Detrusor Contractions During Bladder Filling   [ Time Frame: Baseline and 12 weeks ]

15.  Secondary:   Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction   [ Time Frame: Baseline and 12 weeks ]

16.  Secondary:   Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score   [ Time Frame: 12 weeks ]

17.  Secondary:   Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00386009     History of Changes
Other Study ID Numbers: 11233, H6D-MC-LVHK
Study First Received: October 9, 2006
Results First Received: May 4, 2009
Last Updated: July 1, 2009
Health Authority: United States: Food and Drug Administration