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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;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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 
[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.
Bladder Outlet Obstruction Index (BOOI) [1] 
[Units: Participants]
     
Obstructed (BOOI > 40)   33   34   67 
Equivocal (BOOI 20-40)   35   34   69 
Unobstructed (BOOI < 20)   33   31   64 
[1] 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).
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 [1] 
[Units: Participants]
     
Mild   20   22   42 
Moderate   31   31   62 
Severe   9   5   14 
[1] This measure is only for participants who have Erectile Dysfunction.
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) [1] 
[Units: Kilograms/square centimeters (kg/cm^2)]
Mean (Standard Deviation)
 29.44  (4.47)   29.45  (4.93)   29.45  (4.69) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
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) 


  Outcome Measures
  Show All Outcome Measures

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


  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
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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.


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



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