Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323140
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypogonadism
Intervention: Drug: testosterone matrix transdermal system

  Participant Flow

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
Treatment No text entered.

Participant Flow:   Overall Study

  Baseline Characteristics

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
Treatment No text entered.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   40 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 49.1  (7.6) 
[Units: Participants]
Female   0 
Male   40 
Region of Enrollment 
[Units: Participants]
United States   40 

  Outcome Measures

1.  Primary:   Percent of Subjects With Testosterone Levels in the Normal Range.   [ Time Frame: Day 29/30 ]

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

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.

Results Point of Contact:  
Name/Title: Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Organization: Watson Laboratories, Inc.
phone: 801-588-6641

Responsible Party: Watson Pharmaceuticals Identifier: NCT01323140     History of Changes
Other Study ID Numbers: TM1103
First Submitted: March 21, 2011
First Posted: March 25, 2011
Results First Submitted: October 2, 2012
Results First Posted: January 1, 2013
Last Update Posted: January 1, 2013