Testosterone Treatment for Hypogonadal Men

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00433199
First received: February 8, 2007
Last updated: November 3, 2011
Last verified: November 2011
Results First Received: May 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypogonadism
Interventions: Drug: Testosterone (T) Gel 1.62%
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
Subjects were recruited in 63 centers in US from February 2007 to April 2007 in clinics. The study was designed with a double-blind period of 182 days on Placebo or Androgel 1.62% followed by an 182 days open-label period on Androgel 1.62%.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects started at a daily dose of 2.50 g testosterone gel 1.62% or matching placebo on Day 1. Within 2 days of each of visits (D14, D28 and D42), the dose was titrated up or down in 1.25 g steps if necessary, based on pre-specified normal range criteria, by an unblinded reviewer. The minimum and maximum daily doses were 1.25 g and 5.0 g.

Reporting Groups
  Description
Placebo Placebo comparator administered during the Double-Blind period only
T-Gel 1.62% Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.

Participant Flow for 2 periods

Period 1:   Double-Blind Period
    Placebo     T-Gel 1.62%  
STARTED     40     234  
COMPLETED     28     168  
NOT COMPLETED     12     66  
Adverse Event                 0                 25  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 2                 5  
Withdrawal by Subject                 8                 19  
Protocol Violation                 1                 10  
Administrative                 1                 5  

Period 2:   Open-Label Period
    Placebo     T-Gel 1.62%  
STARTED     0     219  
COMPLETED     0     185  
NOT COMPLETED     0     34  
Adverse Event                 0                 19  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 0                 3  
Withdrawal by Subject                 0                 7  
Protocol Violation                 0                 2  
Administrative                 0                 1  



  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 comparator administered during the Double-Blind period only
T-Gel 1.62% Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
Total Total of all reporting groups

Baseline Measures
    Placebo     T-Gel 1.62%     Total  
Number of Participants  
[units: participants]
  37     214     251  
Age, Customized [1]
[units: participants]
     
<45 years     7     34     41  
45-54 years     7     83     90  
55-64 years     16     67     83  
>= 65 years     7     30     37  
Gender [1]
[units: participants]
     
Female     0     0     0  
Male     37     214     251  
Region of Enrollment [1]
[units: participants]
     
United States     37     214     251  
[1] The Baseline analysis is presented on the Full analysis set.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112   [ Time Frame: Day 112 ]

2.  Secondary:   Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14   [ Time Frame: Day 14 ]

3.  Secondary:   Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56   [ Time Frame: Day 56 ]

4.  Secondary:   Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182   [ Time Frame: Day 182 ]

5.  Secondary:   Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.   [ Time Frame: Day 266 ]

6.  Secondary:   Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.   [ Time Frame: Day 364 ]


  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 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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-91110


No publications provided by Solvay Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Michael Miller, Pharm. D Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00433199     History of Changes
Other Study ID Numbers: S176.3.104
Study First Received: February 8, 2007
Results First Received: May 27, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration