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The Testosterone Trials in Older Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799617
Recruitment Status : Completed
First Posted : December 1, 2008
Results First Posted : August 28, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Andropause
Interventions Drug: AndroGel® (testosterone gel)
Drug: Placebo
Enrollment 790
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Period Title: Main Testosterone Trial
Started 395 395
Completed [1] 376 [2] 374
Not Completed 19 21
Reason Not Completed
Randomized in error             1             1
Lost to Follow-up             18             20
[1]
The Testosterone Trials are a coordinated set of 7 trials.
[2]
Participants qualified for 1 of the 3 main trials (sexual function, physical function, vitality).
Period Title: Sexual Funtion Trial
Started 234 236
Completed 218 215
Not Completed 16 21
Reason Not Completed
Lost to Follow-up             12             14
No Baseline Data             4             7
Period Title: Physical Function Trial
Started 191 196
Completed 185 185
Not Completed 6 11
Reason Not Completed
Lost to Follow-up             6             11
Period Title: Vitality Trial
Started 236 238
Completed 229 216
Not Completed 7 22
Reason Not Completed
Lost to Follow-up             7             22
Period Title: Cardiovascular Trial
Started 88 82
Completed 73 65
Not Completed 15 17
Reason Not Completed
Month 12 scan not available             15             15
Baseline scan not analyzable             0             2
Period Title: Bone Trial
Started 110 101
Completed 104 85
Not Completed 6 16
Reason Not Completed
Month 12 scan not available             6             16
Period Title: Cognitive Function Trial
Started 247 246
Completed 247 245
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Period Title: Anemia Trial
Started 27 35
Completed 24 32
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             3             3
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel Total
Hide Arm/Group Description

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Total of all reporting groups
Overall Number of Baseline Participants 394 394 788
Hide Baseline Analysis Population Description
Two participants were randomized in error, one in each arm of the study.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Main Testosterone Trial Number Analyzed 394 participants 394 participants 788 participants
72.3  (5.8) 72.1  (5.7) 72.2  (5.8)
Cardiovascular Trial Number Analyzed 73 participants 65 participants 138 participants
70.5  (5.7) 72.0  (5.7) 71.2  (5.7)
Bone Trial Number Analyzed 110 participants 101 participants 211 participants
72.3  (6.3) 72.4  (5.5) 72.4  (5.9)
Cognitive Function Trial Number Analyzed 247 participants 246 participants 493 participants
72.3  (5.8) 72.8  (6.1) 72.6  (5.9)
Anemia Trial Number Analyzed 27 participants 35 participants 62 participants
74.8  (6.0) 75.6  (7.5) 75.2  (6.8)
[1]
Measure Description: Men in the trial were 65 years of age or older.
[2]
Measure Analysis Population Description: The number analyzed differs from the number randomized because 2 participants were randomized in error. Participants in the Sexual Function, Physical Function and Vitality trials are enrolled in the overall Main Testosterone Trial.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants 394 participants 788 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
394
 100.0%
394
 100.0%
788
 100.0%
[1]
Measure Description: All of the participants in this trial of testosterone gel use are men.
[2]
Measure Analysis Population Description: The number of participants analyzed differs from the number randomized because some participants withdrew from the trial before month 12 or did not provide complete follow-up data.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants 394 participants 788 participants
Hispanic or Latino
18
   4.6%
10
   2.5%
28
   3.6%
Not Hispanic or Latino
375
  95.2%
384
  97.5%
759
  96.3%
Unknown or Not Reported
1
   0.3%
0
   0.0%
1
   0.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 394 participants 394 participants 788 participants
Caucasian
348
  88.3%
350
  88.8%
698
  88.6%
African-American
21
   5.3%
20
   5.1%
41
   5.2%
Other
25
   6.3%
24
   6.1%
49
   6.2%
1.Primary Outcome
Title Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Hide Description

Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12.

Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.

The change is measured form the baseline value to Month 12.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 230 229
Mean (Standard Deviation)
Unit of Measure: units on the PDQ-Q4 scale
Baseline Score 1.4  (1.3) 1.4  (1.3)
Change at Month 3 0.6  (1.3) 0.1  (1.1)
Change at Month 6 0.6  (1.5) -0.1  (1.2)
Change at Month 9 0.5  (1.5) -0.1  (1.2)
Change at Month 12 0.2  (1.6) -0.1  (1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.
Method Mixed Models Analysis
Comments Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.38 to 0.78
Estimation Comments [Not Specified]
2.Primary Outcome
Title Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
Hide Description The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.
Time Frame 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 191 196
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 179 participants 179 participants
20
  11.2%
14
   7.8%
Month 6 Number Analyzed 174 participants 171 participants
24
  13.8%
23
  13.5%
Month 9 Number Analyzed 191 participants 159 participants
28
  14.7%
22
  13.8%
Month 12 Number Analyzed 191 participants 196 participants
35
  18.3%
20
  10.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
0.83 to 2.45
Estimation Comments [Not Specified]
3.Primary Outcome
Title Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
Hide Description

The number of participants whose score on the FACIT-Fatigue scale increased by at least 4 points.

Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.

Time Frame 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 236 238
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 219 participants 207 participants
148
  67.6%
138
  66.7%
Month 6 Number Analyzed 217 participants 196 participants
144
  66.4%
126
  64.3%
Month 9 Number Analyzed 206 participants 188 participants
148
  71.8%
127
  67.6%
Month 12 Number Analyzed 236 participants 238 participants
147
  62.3%
120
  50.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.83 to 1.84
Estimation Comments [Not Specified]
4.Primary Outcome
Title Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume
Hide Description Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12
Time Frame 1 year (change in plaque volume measurement from baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Men aged 65 years or > with an average of 2 serum testosterone levels lower than 275 ng/L and enrolled in the CV Trial of the Testosterone Trials between June 2010 and June 2014.
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 73 65
Mean (95% Confidence Interval)
Unit of Measure: mm^3
54
(12 to 97)
14
(-29 to 56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 41
Confidence Interval (2-Sided) 95%
14 to 67
Estimation Comments Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.
5.Primary Outcome
Title Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone
Hide Description Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12
Time Frame 1 year (QCT measurement of BMD change between baseline and month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 110 97
Mean (95% Confidence Interval)
Unit of Measure: mg/cm^3
7.5
(4.8 to 10.3)
0.8
(-1.9 to 3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
4.8 to 8.7
Estimation Comments [Not Specified]
6.Primary Outcome
Title Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)
Hide Description

Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12.

The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR.

Time Frame 1 year (change from baseline to month 6 and month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Men, age 65 years or older with low testosterone and Age-Associated Memory Impairment (AAMI)
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 247 246
Mean (95% Confidence Interval)
Unit of Measure: percentage of change in test score
Baseline Score
14.0
(13.2 to 14.8)
14.4
(13.6 to 15.2)
Change at Month 6
1.1
(-0.1 to 2.3)
1.1
(-0.1 to 2.3)
Change at Month 12
1.3
(0.1 to 2.5)
1.4
(0.3 to 2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments

A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.

The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .88
Comments The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.92 to 0.79
Estimation Comments [Not Specified]
7.Primary Outcome
Title Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
Hide Description

Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline.

Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline.

Time Frame 1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Unexplained anemia is anemia that is not due to the following causes: iron and vitamin B12 deficiency, chronic inflammation and disease, chronic renal insufficiency, myelodysplastic syndromes.
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 27 35
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 24 participants 32 participants
6
  25.0%
4
  12.5%
Month 6 Number Analyzed 22 participants 27 participants
8
  36.4%
3
  11.1%
Month 9 Number Analyzed 24 participants 28 participants
15
  62.5%
2
   7.1%
Month 12 Number Analyzed 24 participants 27 participants
13
  54.2%
4
  14.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.
Statistical Test of Hypothesis P-Value .002
Comments The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.
Method Mixed Models Analysis
Comments The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 31.5
Confidence Interval (2-Sided) 95%
3.7 to 277.8
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Sexual Function Trial - Sexual Desire Domain
Hide Description

Baseline score and the changes in the score of the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II), from baseline to Month 12.

Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 234 236
Mean (Standard Deviation)
Unit of Measure: Score on the DISF-M-II scale
Baseline Score 11.9  (6.7) 11.6  (6.6)
Change at Month 3 3.5  (6.3) 0.7  (5.8)
Change at Month 6 3.5  (6.0) 0.8  (5.6)
Change at Month 9 4.0  (7.4) 0.9  (5.5)
Change at Month 12 2.6  (6.5) 0.0  (5.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.
Method Mixed Models Analysis
Comments Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.93
Confidence Interval (2-Sided) 95%
2.13 to 3.74
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Sexual Function Trial - Erectile Function
Hide Description

Baseline score and the change in score on the International Index of Erectile Function (IIEF) from baseline to Month 12.

Scores on the IIEF range from 0-30, with higher scores indicating better function.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 234 236
Mean (Standard Deviation)
Unit of Measure: Score on the IIEF test scale
Baseline Score 8.0  (8.2) 7.7  (8.2)
Change at Month 3 3.4  (6.1) 1.0  (5.3)
Change at Month 6 3.3  (6.5) 0.5  (6.1)
Change at Month 9 3.4  (6.9) 0.5  (7.1)
Change at Month 12 3.1  (6.9) 1.0  (6.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.
Method Mixed Models Analysis
Comments Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 2.64
Confidence Interval (2-Sided) 95%
1.68 to 3.61
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Hide Description Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12
Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 191 196
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Score 347.7  (69.1) 344.9  (68.5)
Change at Month 3 10.2  (35.8) 4.6  (35.2)
Change at Month 6 8.2  (41.5) 7.8  (41.4)
Change at Month 9 5.3  (50.3) 3.2  (52.4)
Change at Month 12 14.3  (45.9) 5.5  (46.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.09
Confidence Interval (2-Sided) 95%
-3.00 to 11.18
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
Hide Description The number of participants whose score on the physical-function domain (PF-10; range, 0 to 100, with higher scores indicating better function) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) increased by at least 8 points from baseline to Month 12.
Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 184 181
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 176 participants 171 participants
77
  43.8%
59
  34.5%
Month 6 Number Analyzed 171 participants 159 participants
72
  42.1%
73
  45.9%
Month 9 Number Analyzed 172 participants 159 participants
77
  44.8%
60
  37.7%
Month 12 Number Analyzed 184 participants 181 participants
66
  35.9%
58
  32.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.90 to 2.00
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Physical Function Trial - PF 10 Overall Score
Hide Description

Baseline score and the change in score on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short Form Health Survey range from 0 to 100, with higher scores indicating better function.

Scores were measured as the change from baseline to Month 12.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 184 181
Mean (Standard Deviation)
Unit of Measure: Score on the PF-10 test scale
Baseline Score 65.4  (20.0) 64.8  (21.3)
Change at Month 3 5.6  (15.2) 4.2  (13.7)
Change at Month 6 6.5  (16.7) 4.8  (17.0)
Change at Month 9 5.9  (19.4) 3.3  (18.9)
Change at Month 12 5.8  (17.5) 2.4  (17.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.75
Confidence Interval (2-Sided) 95%
0.20 to 5.29
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Vitality Trial - FACIT Fatigue Overall Score
Hide Description Baseline score and change in the FACIT- Fatigue score from baseline to Month 12. Scores on the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.
Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 236 238
Mean (Standard Deviation)
Unit of Measure: Score on the FACIT- Fatigue test scale
Baseline Score 31.6  (6.4) 31.3  (6.4)
Change at Month 3 7.8  (8.4) 7.2  (8.8)
Change at Month 6 7.4  (9.1) 5.9  (9.2)
Change at Month 9 8.6  (9.1) 7.2  (9.2)
Change at Month 12 8.0  (8.4) 6.7  (9.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
-0.04 to 2.46
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Vitality Trial - SF-36 Score
Hide Description Baseline score and change in the SF-36 Vitality Score from baseline to Month 12 Scores on the vitality scale of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating less fatigue.
Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 208 196
Mean (Standard Deviation)
Unit of Measure: Score on the SF-36 vitality scale
Baseline Score 50.6  (13.8) 49.4  (12.6)
Change at Month 3 7.4  (13.6) 5.9  (11.1)
Change at Month 6 7.2  (14.6) 4.5  (11.2)
Change at Month 9 8.4  (14.4) 5.7  (12.3)
Change at Month 12 8.2  (15.3) 6.1  (13.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.41
Confidence Interval (2-Sided) 95%
0.31 to 4.50
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Hide Description

Baseline score and change in the total positive affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.

Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 229 234
Mean (Standard Deviation)
Unit of Measure: Score on the PANAS test scale
Baseline Score 15.3  (3.2) 15.4  (3.5)
Change at Month 3 0.7  (3.2) 0.3  (3.3)
Change at Month 6 0.9  (3.8) 0.0  (3.3)
Change at Month 9 0.9  (3.4) 0.4  (3.4)
Change at Month 12 0.7  (3.9) 0.2  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.02 to 0.92
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Hide Description

Baseline score and change in the total negative affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.

Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 229 234
Mean (Standard Deviation)
Unit of Measure: Score on the PANAS test scale
Baseline Score 7.5  (2.7) 7.4  (2.8)
Change at Month 3 -0.2  (2.5) 0.3  (2.4)
Change at Month 6 -0.4  (2.4) 0.4  (2.6)
Change at Month 9 -0.2  (2.3) -0.1  (2.6)
Change at Month 12 -0.6  (2.1) -0.1  (2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Treatment Effect
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.79 to -0.19
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Hide Description

Baseline score and change in score in the Patient Health Questionnaire 9 (PHQ-9) from baseline to Month 12.

Scores on the Patient Health Questionnaire 9 (PHQ-9) depression scale range from 0 to 27, with higher scores indicating greater intensity of depressive symptoms.

Time Frame 1 year (change from baseline to month 3, 6, 9 and 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 230 234
Mean (Standard Deviation)
Unit of Measure: Score on the PHQ-9 test scale
Baseline Score 6.6  (4.0) 6.6  (4.0)
Change at Month 3 -1.3  (3.8) -0.8  (3.5)
Change at Month 6 -1.7  (3.8) -0.5  (3.7)
Change at Month 9 -1.9  (4.0) -1.2  (4.2)
Change at Month 12 -1.8  (3.7) -1.1  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.
Method Treatment Effect
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.20 to -0.23
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Cardiovascular Trial - Total Plaque Volume Change From Baseline
Hide Description Total plaque volume,mm3 measured by coronary computed tomographic angiography
Time Frame 1 year (change from baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 73 65
Mean (95% Confidence Interval)
Unit of Measure: mm^3
75
(22 to 128)
28
(-24 to 81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 47
Confidence Interval (2-Sided) 95%
13 to 80
Estimation Comments Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.
19.Secondary Outcome
Title Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline
Hide Description Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis).
Time Frame 1 year (change from baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with measurements of both baseline and 12-month assessments were included in the analysis.
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 73 65
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Agatston units
64
(-19 to 146)
91
(7 to 174)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .31
Comments Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27
Confidence Interval (2-Sided) 95%
-80 to 26
Estimation Comments Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.
20.Secondary Outcome
Title Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)
Hide Description Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 110 97
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
4.0
(2.9 to 5.2)
1.1
(0.0 to 2.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
2.1 to 3.7
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)
Hide Description Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 110 97
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
5.5
(4.0 to 6.9)
1.2
(-0.2 to 2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
3.2 to 5.3
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)
Hide Description Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 103 88
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.6
(0.8 to 2.4)
0.1
(-0.6 to 0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.9 to 2.0
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)
Hide Description Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 103 88
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.6
(0.9 to 2.3)
0.7
(-0.0 to 1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.5 to 1.5
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)
Hide Description Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 103 88
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.7
(1.0 to 2.4)
0.4
(-0.2 to 1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.8 to 1.7
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N
Hide Description Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 110 97
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
9.0
(6.4 to 11.6)
1.9
(-0.6 to 4.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
5.3 to 809
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N
Hide Description Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 110 97
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
10.8
(7.4 to 14.3)
2.4
(-1.0 to 5.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
6.0 to 10.9
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N
Hide Description Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 110 97
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
7.2
(5.2 to 9.2)
1.5
(-0.5 to 3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.7
Confidence Interval (2-Sided) 95%
4.3 to 7.2
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N
Hide Description Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 103 88
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
2.5
(1.4 to 3.5)
0.6
(-0.4 to 1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
1.1 to 2.6
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N
Hide Description Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 103 88
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.5
(0.5 to 2.5)
0.5
(-0.5 to 1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .005
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.3 to 1.7
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N
Hide Description Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 103 88
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.4
(0.7 to 2.0)
0.4
(-0.3 to 1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.5 to 1.4
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)
Hide Description Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 109 101
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
3.3
(2.01 to 4.56)
2.1
(0.87 to 3.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.25 to 2.09
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)
Hide Description Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 108 100
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.2
(0.19 to 2.17)
0.5
(-0.45 to 1.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .052
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .07
Confidence Interval (2-Sided) 95%
-0.01 to 1.36
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)
Hide Description Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 108 100
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
1.5
(0.02 to 2.97)
0.9
(-0.49 to 2.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments

Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.

The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.

Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-0.45 to 1.58
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)
Hide Description

Baseline score and mean change in score in the Visual Memory Using the Benton Visual Retention Test (BVRT) from baseline, Month 6 and Month 12.

The BVRT measures short term visual memory and visuo-constructional abilities and was administered and scored according to standard procedures. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score was the total number of figures with errors and ranged from 0 to 26. Scores were inverted to 0 to -26 so that higher scores would reflect better performance.

Change in BVRT scores from baseline are treated as continuous and compared between AAMI Androgel and placebo subjects using linear random effects models adjusting for balancing factors as described in the primary analysis.

Time Frame 1 year (baseline to month 6 and month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 246 246
Mean (95% Confidence Interval)
Unit of Measure: Score on the BVRT test scale
Baseline Score
-8.2
(-8.6 to -7.8)
-8.2
(-8.6 to -7.8)
Change at Month 6
0.2
(-0.4 to 0.9)
0.3
(-0.3 to 1.0)
Change at Month 12
0.3
(-0.4 to 0.9)
0.7
(0.0 to 1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .24
Comments The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.76 to 0.19
Estimation Comments The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.
35.Secondary Outcome
Title Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)
Hide Description

Baseline score and change in score in the Spatial Ability Using the Card Rotation Test at baseline, Month 6 and Month 12.

Change in performance on the Card Rotations Test will be analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version. The test consists of a series of 10 primary figures, each of which has 8 corresponding secondary figures. Subjects are asked to determine which of the secondary figures is the same as the corresponding primary figure, and the score is taken as the number of figures answered correctly minus the number of figures answered incorrectly.

The maximum score is 80 for subjects who answer all items correctly.

Time Frame 1 year (baseline to month 6 to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 245 243
Mean (95% Confidence Interval)
Unit of Measure: Score on the CRT test scale
Baseline Score
28.7
(26.9 to 30.5)
30.0
(28.1 to 31.8)
Change at Month 6
0.6
(-1.9 to 30.)
0.2
(-2.3 to 2.7)
Change at Month 12
0.6
(-1.8 to 3.1)
1.2
(-1.3 to 3.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .89
Comments The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-1.89 to 1.65
Estimation Comments The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.
36.Secondary Outcome
Title Cognitive Function Trial - Executive Function - Trail Making Test B - A
Hide Description

Baseline score and change in score in Executive Function as Measured by Trail-Making Test (TMT) B - A, at baseline, Month 6 and Month 12.

Change in performance on the Trail Making Test was analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version.

Participants are required to connect a set of numbers (Part A) or alternating letters and numbers (Part B) in sequential order. The score for each part is the total time (in seconds) to complete both parts. The outcome analyzed will be the total time for Trails B minus the total time for Trails A to provide a measure of working memory, adjusted for attention and processing speed. Higher scores reflect lower executive function.

Time Frame 1 year (baseline to month 6 to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 245 245
Mean (95% Confidence Interval)
Unit of Measure: Score on the Trail Making Test scale
Baseline Score
86.4
(78.3 to 94.6)
76.7
(69.9 to 83.5)
Change at Month 6
-2.1
(-12.4 to 8.2)
1.8
(-8.6 to 12.2)
Change at Month 12
-0.0
(-10.3 to 10.3)
7.1
(-3.3 to 17.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .14
Comments The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.51
Confidence Interval (2-Sided) 95%
-12.91 to 1.88
Estimation Comments The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.
37.Secondary Outcome
Title Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)
Hide Description

Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 gm/dL from baseline.

Values are means (SDs) for continuous outcomes.

Time Frame 1 year (baseline to month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description:

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

Overall Number of Participants Analyzed 27 35
Mean (Standard Deviation)
Unit of Measure: proportion of participants
0.9  (1.4) 0.2  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AndroGel® (Testosterone Gel), Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.48 to 1.39
Estimation Comments Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.
Time Frame Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
Adverse Event Reporting Description

All adverse events were coded by an independent expert. Cardiovascular adverse events were collected by a specific questionnaire administered at each visit during treatment and for one year after treatment.

Cardiovascular adverse events were also identified from the Adverse Event log and SAE Report Forms. Cardiovascular events were adjudicated.

Myocardial infarction, stroke and death were adjudicated by two adjudicators, and all other events by one adjudicator.

 
Arm/Group Title AndroGel® (Testosterone Gel) Placebo Gel
Hide Arm/Group Description

AndroGel is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to wash their hands after application and not to have contact with women or children while the gel is wet. They will also be asked not to bathe or get this area wet for five hours after application. The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day.

AndroGel® (testosterone gel): Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range.

Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Subjects will be instructed to follow the same precautions to avoid contact with others.

Placebo: Testosterone levels will be measured at regular intervals.

All-Cause Mortality
AndroGel® (Testosterone Gel) Placebo Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
AndroGel® (Testosterone Gel) Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   183/394 (46.45%)      176/394 (44.67%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  2/394 (0.51%)  2 2/394 (0.51%)  2
Cardiac disorders     
Cardiac disorders  1  35/394 (8.88%)  38 34/394 (8.63%)  42
Gastrointestinal disorders     
Gastrointestinal disorders  1  10/394 (2.54%)  10 7/394 (1.78%)  8
General disorders     
General disorders  1  12/394 (3.05%)  13 14/394 (3.55%)  15
Hepatobiliary disorders     
Hepatobiliary disorders  1  4/394 (1.02%)  4 2/394 (0.51%)  3
Infections and infestations     
Infections and infestations  1  29/394 (7.36%)  34 21/394 (5.33%)  25
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1  9/394 (2.28%)  11 11/394 (2.79%)  14
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  1/394 (0.25%)  1 4/394 (1.02%)  4
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  22/394 (5.58%)  24 19/394 (4.82%)  22
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified  1  15/394 (3.81%)  16 12/394 (3.05%)  14
Nervous system disorders     
Nervous system disorders  1  16/394 (4.06%)  17 22/394 (5.58%)  24
Psychiatric disorders     
Psychiatric disorders  1  3/394 (0.76%)  5 1/394 (0.25%)  1
Renal and urinary disorders     
Renal and urinary disorders  1  4/394 (1.02%)  5 1/394 (0.25%)  1
Reproductive system and breast disorders     
Reproductive system and breast disorders  1  1/394 (0.25%)  1 1/394 (0.25%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory disorders  1  9/394 (2.28%)  10 17/394 (4.31%)  22
Surgical and medical procedures     
Surgical and medical procedures  1  1/394 (0.25%)  1 1/394 (0.25%)  1
Vascular disorders     
Vascular disorders  1  10/394 (2.54%)  12 7/394 (1.78%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AndroGel® (Testosterone Gel) Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   343/394 (87.06%)      341/394 (86.55%)    
Cardiac disorders     
Cardiac disorders  1  45/394 (11.42%)  82 45/394 (11.42%)  88
Eye disorders     
Eye disorders  1  23/394 (5.84%)  27 27/394 (6.85%)  36
Gastrointestinal disorders     
Gastrointestinal disorders  1  65/394 (16.50%)  99 71/394 (18.02%)  116
General disorders     
General disorders and administration site conditions  1  74/394 (18.78%)  115 75/394 (19.04%)  99
Infections and infestations     
Infections and infestations  1  152/394 (38.58%)  221 145/394 (36.80%)  220
Injury, poisoning and procedural complications     
Injury poisoning and procedural complications  1  87/394 (22.08%)  143 89/394 (22.59%)  160
Investigations     
Investigations  1  45/394 (11.42%)  59 37/394 (9.39%)  54
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  24/394 (6.09%)  31 29/394 (7.36%)  34
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  145/394 (36.80%)  272 155/394 (39.34%)  293
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (including cysts and polyps)  1  28/394 (7.11%)  35 22/394 (5.58%)  27
Nervous system disorders     
Nervous system disorders  1  75/394 (19.04%)  101 78/394 (19.80%)  107
Psychiatric disorders     
Psychiatric disorders  1  26/394 (6.60%)  41 27/394 (6.85%)  37
Renal and urinary disorders     
Renal and urinary disorders  1  43/394 (10.91%)  59 42/394 (10.66%)  53
Reproductive system and breast disorders     
Reproductive system and breast disorders  1  49/394 (12.44%)  63 19/394 (4.82%)  22
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  1  74/394 (18.78%)  110 67/394 (17.01%)  106
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  1  88/394 (22.34%)  156 52/394 (13.20%)  75
Surgical and medical procedures     
Surgical and medical procedures  1  36/394 (9.14%)  55 31/394 (7.87%)  43
Vascular disorders     
Vascular disorders  1  33/394 (8.38%)  42 34/394 (8.63%)  43
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Peter J. Snyder, MD
Organization: University of Pennsylvania, Perelman School of Medicine
Phone: 215-898-0208
EMail: pjsnyder@upenn.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00799617    
Other Study ID Numbers: U01AG030644 ( U.S. NIH Grant/Contract )
R01AG037679 ( U.S. NIH Grant/Contract )
First Submitted: November 26, 2008
First Posted: December 1, 2008
Results First Submitted: January 3, 2017
Results First Posted: August 28, 2017
Last Update Posted: February 21, 2019