A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00857454
First received: March 4, 2009
Last updated: December 15, 2010
Last verified: December 2010
Results First Received: December 15, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypogonadism
Intervention: Drug: Testosterone MD-Lotion

  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 was an open-label extension to the MTE08 trial. Only participants in the MTE08 trial who consented and met eligibility criteria could be enrolled in MTE09.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants received 3.0 mL (60 mg) of 2% Testosterone MD-Lotion for 60 days, and may have had their dose adjusted upwards or downwards (Subjects in MTE09 were continued on the dose that they were taking at the conclusion of study MTE08. A total of 2 patients received 30 mg; 49 remained on 60 mg, 12 received 90 mg; and 8 received 120 mg).

Reporting Groups
  Description
Testosterone MD-lotion 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days

Participant Flow:   Overall Study
    Testosterone MD-lotion  
STARTED     71  
COMPLETED     51  
NOT COMPLETED     20  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  
Adverse Event                 2  
Total Testosterone >1050 ng/dL                 1  
Total Testosterone <300 ng/dL                 8  
MTE09 enrollment criteria not met                 6  



  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
Testosterone MD-lotion 30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days

Baseline Measures
    Testosterone MD-lotion  
Number of Participants  
[units: participants]
  71  
Age  
[units: years]
Mean ± Standard Deviation
  52.3  ± 12.13  
Gender  
[units: participants]
 
Female     0  
Male     71  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     54  
African American     6  
Hispanic     10  
Other     1  
Region of Enrollment  
[units: participants]
 
United States     71  
Body Mass Index (BMI) [1]
[units: kilograms per square metter (kg/m^2)]
Mean ± Standard Deviation
  29.78  ± 3.61  
Baseline Total Testosterone Level  
[units: nanograms per deciliter (ng/dL)]
Mean ± Standard Deviation
  217.93  ± 84.70  
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.



  Outcome Measures
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1.  Primary:   Change From Baseline MTE08 to MTE09 Endpoint in Draize Score   [ Time Frame: Day 1, Day 190 ]

2.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin   [ Time Frame: Day 1, up to Day 190 ]

3.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose   [ Time Frame: Day 1, up to Day 190 ]

4.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)   [ Time Frame: Day 1, up to Day 190 ]

5.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)   [ Time Frame: Day 1, up to Day 190 ]

6.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Estradiol   [ Time Frame: Day 1, up to Day 190 ]

7.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin   [ Time Frame: Day 1, up to Day 190 ]

8.  Secondary:   Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit   [ Time Frame: Day 1, up to Day 190 ]


  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
No text entered.


  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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00857454     History of Changes
Other Study ID Numbers: 14273, MTE09, I5E-MC-TSAI
Study First Received: March 4, 2009
Results First Received: December 15, 2010
Last Updated: December 15, 2010
Health Authority: United States: Food and Drug Administration