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A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations

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ClinicalTrials.gov Identifier: NCT00702650
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : January 5, 2011
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypogonadism
Intervention: Drug: Testosterone MD-Lotion

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects received Testosterone Metered Dose (MD)-Lotion for 120 days, at initial dose of 60 mg; may have had their dose adjusted up or down on Days 45 and 90 (3 were on 30mg; 97 on 60mg; 25 on 90mg; and 10 on 120mg). As primary outcome=subjects with normal testosterone at Day 120, results are presented for overall treatment group rather than dose.

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

Participant Flow:   Overall Study
    Testosterone MD-Lotion
STARTED   155 
COMPLETED   135 
NOT COMPLETED   20 
Withdrawal by Subject                9 
Non-Compliance of Study Drug                3 
Lost to Follow-up                2 
Non-Compliance with Site Directives                1 
Sponsor Request                1 
Screening Testosterone Levels >300 ng/dL                1 
Adverse Event                3 



  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.
No text entered.

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

Baseline Measures
   Testosterone MD-Lotion 
Overall Participants Analyzed 
[Units: Participants]
 155 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.5  (12.7) 
Gender 
[Units: Participants]
 
Female   0 
Male   155 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   1 
Caucasian   122 
African American   6 
Hispanic   13 
Other - Not Specified   2 
Missing   11 
Region of Enrollment 
[Units: Participants]
 
France   11 
United States   104 
Australia   10 
Germany   9 
United Kingdom   10 
Sweden   11 
Body Mass Index (BMI) [1] 
[Units: Kilograms per square meter (kg/m^2)]
Mean (Standard Deviation)
 29.53  (3.60) 
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.
Baseline Total Testosterone Level 
[Units: Nanograms per deciliter (ng/dL)]
Mean (Standard Deviation)
 196.73  (91.04) 


  Outcome Measures

1.  Primary:   Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120   [ Time Frame: Day 120 ]

2.  Secondary:   Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL   [ Time Frame: Day 120 ]

3.  Secondary:   Percentage of Participants With Cmax Between 1800 and 2500 ng/dL   [ Time Frame: Day 120 ]

4.  Secondary:   Percentage of Participants With Cmax >2500 ng/dL   [ Time Frame: Day 120 ]

5.  Secondary:   Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL   [ Time Frame: Day 120 ]

6.  Secondary:   Change From Baseline to Endpoint in Psychosexual Daily Questionnaire   [ Time Frame: Baseline, Day 120 ]

7.  Secondary:   Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)   [ Time Frame: Baseline, Day 120 ]

8.  Secondary:   Change From Baseline to Endpoint in Fasting Insulin   [ Time Frame: Baseline, up to Day 120 ]

9.  Secondary:   Change From Baseline to Endpoint in Fasting Glucose   [ Time Frame: Baseline, up to Day 120 ]

10.  Secondary:   Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)   [ Time Frame: Baseline, Day 120 ]

11.  Secondary:   Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)   [ Time Frame: Baseline, up to Day 120 ]

12.  Secondary:   Change From Baseline to Endpoint in Estradiol   [ Time Frame: Baseline, up to Day 120 ]

13.  Secondary:   Change From Baseline to Endpoint in Haemoglobin   [ Time Frame: Baseline, up to Day 120 ]

14.  Secondary:   Change From Baseline to Endpoint in Haematocrit   [ Time Frame: Baseline, up to Day 120 ]

15.  Secondary:   Change From Baseline to Endpoint in Draize Score   [ Time Frame: Baseline, Day 120 ]


  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
No text entered.


  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 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


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00702650     History of Changes
Other Study ID Numbers: 14272
MTE08 ( Other Identifier: Acrux )
I5E-MC-TSAH ( Other Identifier: Eli Lilly and Company )
First Submitted: June 19, 2008
First Posted: June 20, 2008
Results First Submitted: December 15, 2010
Results First Posted: January 5, 2011
Last Update Posted: July 25, 2011