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Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01104246
First received: April 13, 2010
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
Results First Received: February 1, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypogonadism
Intervention: Drug: Testerone Transdermal System

  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
Testosterone Transdermal Systems Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.

Participant Flow:   Overall Study
    Testosterone Transdermal Systems  
STARTED     40  
Baseline Characteristics Measured     35  
COMPLETED     35  
NOT COMPLETED     5  
Withdrawal by Subject                 1  
did not meet inclusion criteria                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Testosterone Transdermal Systems Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.

Baseline Measures
    Testosterone Transdermal Systems  
Number of Participants  
[units: participants]
 		  35  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     32  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation 		  55.1  ± 8.70  
Gender  
[units: participants]
 		 
Female     0  
Male     35  
Region of Enrollment  
[units: participants]
 		 
United States     35  



  Outcome Measures

1.  Primary:   Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours   [ Time Frame: Day 28/29 ]
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  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 more than 60 days but less than or equal to 180 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
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Results Point of Contact:  
Name/Title: Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Organization: Watson Laboratories, Inc.
phone: 801-588-6641
e-mail: gary.hoel@watson.com


No publications provided


Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01104246     History of Changes
Other Study ID Numbers: AND1001
Study First Received: April 13, 2010
Results First Received: February 1, 2011
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration