Time to Eugonadal Range, Time to Steady State and Drying Time

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01228071
First received: October 22, 2010
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: March 27, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Male Hypogonadism
Intervention: Drug: testosterone gel 2%

  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
This multicenter, open-label, single-arm phase 3B trial was initiated on November 9, 2010 and completed on May 6, 2011 in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After the 3-week screening period and fulfilling the eligibility criteria, 34 hypogonadal men were enrolled in the study.

Reporting Groups
  Description
40 mg Daily Dose of Testosterone Gel 2%

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%


Participant Flow:   Overall Study
    40 mg Daily Dose of Testosterone Gel 2%  
STARTED     34  
COMPLETED     32  
NOT COMPLETED     2  
Protocol Violation                 1  
Withdrawal by Subject                 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.
The pharmacokinetic (PK) population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data. All subjects who received at least 1 dose of study drug were included in the safety population.

Reporting Groups
  Description
40 mg Daily Dose of Testosterone Gel 2%

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%


Baseline Measures
    40 mg Daily Dose of Testosterone Gel 2%  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 10.01  
Gender  
[units: participants]
 
Female     0  
Male     34  
Region of Enrollment  
[units: participants]
 
United States     34  



  Outcome Measures
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1.  Primary:   Time to Target Eugonadal Range   [ Time Frame: 24 hours ]

2.  Primary:   Time to Steady State (SS)   [ Time Frame: 14 days ]

3.  Primary:   Gel Drying Time   [ Time Frame: 1 day; drying time measured following gel application on Day 14 ]


  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 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: Peter B. Langmuir, MD
Organization: Endo Pharmaceutical Clinical Development & Medical Science
phone: +1-484-216-7514
e-mail: langmuir.peter@endo.com


No publications provided


Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01228071     History of Changes
Other Study ID Numbers: EN3350-302
Study First Received: October 22, 2010
Results First Received: March 27, 2013
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration