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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
Enrollment 155
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description 30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Period Title: Overall Study
Started 155
Completed 135
Not Completed 20
Reason Not Completed
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
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description 30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Baseline Participants 155
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants
51.5  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants
Female
0
   0.0%
Male
155
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants
Asian 1
Caucasian 122
African American 6
Hispanic 13
Other - Not Specified 2
Missing 11
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants
France 11
United States 104
Australia 10
Germany 9
United Kingdom 10
Sweden 11
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meter (kg/m^2)
Number Analyzed 155 participants
29.53  (3.60)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight divided by height squared.
Baseline Total Testosterone Level  
Mean (Standard Deviation)
Unit of measure:  Nanograms per deciliter (ng/dL)
Number Analyzed 155 participants
196.73  (91.04)
1.Primary Outcome
Title Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120
Hide Description Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures).
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 138
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.1
(77.95 to 90.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method One-Sample Binomial (Wald) test, 2-sided
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL
Hide Description Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: percentage of participants
5.2
3.Secondary Outcome
Title Percentage of Participants With Cmax Between 1800 and 2500 ng/dL
Hide Description Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: percentage of participants
3.0
4.Secondary Outcome
Title Percentage of Participants With Cmax >2500 ng/dL
Hide Description Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: percentage of participants
0.7
5.Secondary Outcome
Title Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL
Hide Description Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 135
Measure Type: Number
Unit of Measure: percentage of participants
64.4
6.Secondary Outcome
Title Change From Baseline to Endpoint in Psychosexual Daily Questionnaire
Hide Description Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).
Time Frame Baseline, Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 131
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sexual Desire 1.49  (1.84)
Overall Sexual Activity Score 0.94  (1.43)
Erection Maintained for Satisfactory Duration 1.11  (2.0)
Positive Mood 0.56  (1.25)
Negative Mood -0.50  (1.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)
Hide Description The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).
Time Frame Baseline, Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 133
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Component Score 1.55  (7.72)
Mental Component Score 4.54  (9.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0254
Comments p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone MD-Lotion
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Endpoint in Fasting Insulin
Hide Description [Not Specified]
Time Frame Baseline, up to Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: uIU/mL
1.93  (12.02)
9.Secondary Outcome
Title Change From Baseline to Endpoint in Fasting Glucose
Hide Description [Not Specified]
Time Frame Baseline, up to Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.41  (20.02)
10.Secondary Outcome
Title Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)
Hide Description [Not Specified]
Time Frame Baseline, Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.13  (0.68)
11.Secondary Outcome
Title Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Hide Description [Not Specified]
Time Frame Baseline, up to Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: mIU/mL
Luteinizing Hormone (N=48) -2.04  (5.36)
Follicle Stimulating Hormone (N=54) -2.41  (9.72)
12.Secondary Outcome
Title Change From Baseline to Endpoint in Estradiol
Hide Description [Not Specified]
Time Frame Baseline, up to Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: pg/mL
-2.16  (12.32)
13.Secondary Outcome
Title Change From Baseline to Endpoint in Haemoglobin
Hide Description [Not Specified]
Time Frame Baseline, up to Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: g/dL
0.51  (1.08)
14.Secondary Outcome
Title Change From Baseline to Endpoint in Haematocrit
Hide Description Haematocrit: percentage of total blood volume made up of blood cells
Time Frame Baseline, up to Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: percentage of red blood cells
0.02  (0.04)
15.Secondary Outcome
Title Change From Baseline to Endpoint in Draize Score
Hide Description Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.
Time Frame Baseline, Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description:
30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
Overall Number of Participants Analyzed 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (0.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone MD-Lotion
Hide Arm/Group Description 30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
All-Cause Mortality
Testosterone MD-Lotion
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone MD-Lotion
Affected / at Risk (%) # Events
Total   1/155 (0.65%)    
Infections and infestations   
Appendicitis  1  1/155 (0.65%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Testosterone MD-Lotion
Affected / at Risk (%) # Events
Total   80/155 (51.61%)    
Gastrointestinal disorders   
Diarrhoea  1  4/155 (2.58%)  4
Gastrooesophageal reflux disease  1  2/155 (1.29%)  2
Nausea  1  2/155 (1.29%)  3
Vomiting  1  4/155 (2.58%)  4
General disorders   
Application site erythema  1  8/155 (5.16%)  9
Application site irritation  1  11/155 (7.10%)  19
Application site oedema  1  2/155 (1.29%)  2
Application site warmth  1  2/155 (1.29%)  4
Fatigue  1  3/155 (1.94%)  3
Pyrexia  1  3/155 (1.94%)  3
Infections and infestations   
Fungal infection  1  2/155 (1.29%)  2
Influenza  1  3/155 (1.94%)  3
Nasopharyngitis  1  6/155 (3.87%)  8
Rhinitis  1  2/155 (1.29%)  2
Upper respiratory tract infection  1  3/155 (1.94%)  3
Injury, poisoning and procedural complications   
Epicondylitis  1  2/155 (1.29%)  2
Investigations   
Blood glucose increased  1  2/155 (1.29%)  2
Haematocrit increased  1  6/155 (3.87%)  6
Haemoglobin increased  1  2/155 (1.29%)  2
Prostatic specific antigen increased  1  2/155 (1.29%)  2
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  2/155 (1.29%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/155 (1.94%)  5
Back pain  1  2/155 (1.29%)  2
Musculoskeletal pain  1  2/155 (1.29%)  2
Myalgia  1  2/155 (1.29%)  2
Nervous system disorders   
Dizziness  1  2/155 (1.29%)  2
Headache  1  8/155 (5.16%)  11
Migraine  1  2/155 (1.29%)  2
Presyncope  1  2/155 (1.29%)  2
Psychiatric disorders   
Anger  1  2/155 (1.29%)  4
Anxiety  1  2/155 (1.29%)  3
Insomnia  1  3/155 (1.94%)  3
Stress  1  2/155 (1.29%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/155 (1.29%)  2
Paranasal sinus hypersecretion  1  3/155 (1.94%)  3
Sinus congestion  1  2/155 (1.29%)  2
Skin and subcutaneous tissue disorders   
Acne  1  2/155 (1.29%)  2
Erythema  1  2/155 (1.29%)  2
Hyperkeratosis  1  2/155 (1.29%)  2
Vascular disorders   
Hypertension  1  3/155 (1.94%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
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