A Study of Tadalafil in Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01183650
First received: August 13, 2010
Last updated: April 19, 2012
Last verified: April 2012
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Benign Prostatic Hyperplasia
Intervention: Drug: Tadalafil

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Japanese Participants Japanese participants who received 5 mg of tadalafil once daily for 10 days
Caucasian Participants Caucasian participants who received 5 mg of tadalafil once daily for 10 days

Participant Flow:   Overall Study
    Japanese Participants     Caucasian Participants  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Japanese Participants Japanese participants who received 5 mg of tadalafil once daily for 10 days
Caucasian Participants Caucasian participants who received 5 mg of tadalafil once daily for 10 days
Total Total of all reporting groups

Baseline Measures
    Japanese Participants     Caucasian Participants     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: years]
Mean ± Standard Deviation
  57.0  ± 9.9     60.6  ± 7.2     58.8  ± 8.7  
Gender  
[units: participants]
     
Female     0     0     0  
Male     12     12     24  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     12     12     24  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     12     0     12  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     12     12  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Germany     0     12     12  
Japan     12     0     12  



  Outcome Measures
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1.  Primary:   Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710   [ Time Frame: 1 day and 10 days ]

2.  Primary:   Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710   [ Time Frame: 1 day and 10 days ]

3.  Primary:   Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710   [ Time Frame: 1 day and 10 days ]


  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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01183650     History of Changes
Other Study ID Numbers: 13910, H6D-MC-LVIY
Study First Received: August 13, 2010
Results First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency