Trial Outcomes & Findings for The Testosterone Trials in Older Men (NCT NCT00799617)
NCT ID: NCT00799617
Last Updated: 2019-02-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
790 participants
Primary outcome timeframe
1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)
Results posted on
2019-02-21
Participant Flow
Participant milestones
| Measure |
AndroGel® (Testosterone Gel)
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
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.
|
|---|---|---|
|
Main Testosterone Trial
STARTED
|
395
|
395
|
|
Main Testosterone Trial
COMPLETED
|
376
|
374
|
|
Main Testosterone Trial
NOT COMPLETED
|
19
|
21
|
|
Sexual Funtion Trial
STARTED
|
234
|
236
|
|
Sexual Funtion Trial
COMPLETED
|
218
|
215
|
|
Sexual Funtion Trial
NOT COMPLETED
|
16
|
21
|
|
Physical Function Trial
STARTED
|
191
|
196
|
|
Physical Function Trial
COMPLETED
|
185
|
185
|
|
Physical Function Trial
NOT COMPLETED
|
6
|
11
|
|
Vitality Trial
STARTED
|
236
|
238
|
|
Vitality Trial
COMPLETED
|
229
|
216
|
|
Vitality Trial
NOT COMPLETED
|
7
|
22
|
|
Cardiovascular Trial
STARTED
|
88
|
82
|
|
Cardiovascular Trial
COMPLETED
|
73
|
65
|
|
Cardiovascular Trial
NOT COMPLETED
|
15
|
17
|
|
Bone Trial
STARTED
|
110
|
101
|
|
Bone Trial
COMPLETED
|
104
|
85
|
|
Bone Trial
NOT COMPLETED
|
6
|
16
|
|
Cognitive Function Trial
STARTED
|
247
|
246
|
|
Cognitive Function Trial
COMPLETED
|
247
|
245
|
|
Cognitive Function Trial
NOT COMPLETED
|
0
|
1
|
|
Anemia Trial
STARTED
|
27
|
35
|
|
Anemia Trial
COMPLETED
|
24
|
32
|
|
Anemia Trial
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
AndroGel® (Testosterone Gel)
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
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.
|
|---|---|---|
|
Main Testosterone Trial
Randomized in error
|
1
|
1
|
|
Main Testosterone Trial
Lost to Follow-up
|
18
|
20
|
|
Sexual Funtion Trial
Lost to Follow-up
|
12
|
14
|
|
Sexual Funtion Trial
No Baseline Data
|
4
|
7
|
|
Physical Function Trial
Lost to Follow-up
|
6
|
11
|
|
Vitality Trial
Lost to Follow-up
|
7
|
22
|
|
Cardiovascular Trial
Month 12 scan not available
|
15
|
15
|
|
Cardiovascular Trial
Baseline scan not analyzable
|
0
|
2
|
|
Bone Trial
Month 12 scan not available
|
6
|
16
|
|
Cognitive Function Trial
Lost to Follow-up
|
0
|
1
|
|
Anemia Trial
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
AndroGel® (Testosterone Gel)
n=394 Participants
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
n=394 Participants
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
n=788 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Main Testosterone Trial
|
72.3 years
STANDARD_DEVIATION 5.8 • n=394 Participants • 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.
|
72.1 years
STANDARD_DEVIATION 5.7 • n=394 Participants • 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.
|
72.2 years
STANDARD_DEVIATION 5.8 • n=788 Participants • 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.
|
|
Age, Continuous
Cardiovascular Trial
|
70.5 years
STANDARD_DEVIATION 5.7 • n=73 Participants • 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.
|
72.0 years
STANDARD_DEVIATION 5.7 • n=65 Participants • 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.
|
71.2 years
STANDARD_DEVIATION 5.7 • n=138 Participants • 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.
|
|
Age, Continuous
Bone Trial
|
72.3 years
STANDARD_DEVIATION 6.3 • n=110 Participants • 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.
|
72.4 years
STANDARD_DEVIATION 5.5 • n=101 Participants • 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.
|
72.4 years
STANDARD_DEVIATION 5.9 • n=211 Participants • 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.
|
|
Age, Continuous
Cognitive Function Trial
|
72.3 years
STANDARD_DEVIATION 5.8 • n=247 Participants • 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.
|
72.8 years
STANDARD_DEVIATION 6.1 • n=246 Participants • 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.
|
72.6 years
STANDARD_DEVIATION 5.9 • n=493 Participants • 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.
|
|
Age, Continuous
Anemia Trial
|
74.8 years
STANDARD_DEVIATION 6.0 • n=27 Participants • 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.
|
75.6 years
STANDARD_DEVIATION 7.5 • n=35 Participants • 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.
|
75.2 years
STANDARD_DEVIATION 6.8 • n=62 Participants • 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
Female
|
0 Participants
n=394 Participants • 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.
|
0 Participants
n=394 Participants • 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.
|
0 Participants
n=788 Participants • 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.
|
|
Sex: Female, Male
Male
|
394 Participants
n=394 Participants • 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.
|
394 Participants
n=394 Participants • 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.
|
788 Participants
n=788 Participants • 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)
Hispanic or Latino
|
18 Participants
n=394 Participants
|
10 Participants
n=394 Participants
|
28 Participants
n=788 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
375 Participants
n=394 Participants
|
384 Participants
n=394 Participants
|
759 Participants
n=788 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=394 Participants
|
0 Participants
n=394 Participants
|
1 Participants
n=788 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
348 Participants
n=394 Participants
|
350 Participants
n=394 Participants
|
698 Participants
n=788 Participants
|
|
Race/Ethnicity, Customized
Race · African-American
|
21 Participants
n=394 Participants
|
20 Participants
n=394 Participants
|
41 Participants
n=788 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
25 Participants
n=394 Participants
|
24 Participants
n=394 Participants
|
49 Participants
n=788 Participants
|
PRIMARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=230 Participants
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
n=229 Participants
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.
|
|---|---|---|
|
Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Change at Month 12
|
0.2 units on the PDQ-Q4 scale
Standard Deviation 1.6
|
-0.1 units on the PDQ-Q4 scale
Standard Deviation 1.4
|
|
Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Baseline Score
|
1.4 units on the PDQ-Q4 scale
Standard Deviation 1.3
|
1.4 units on the PDQ-Q4 scale
Standard Deviation 1.3
|
|
Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Change at Month 3
|
0.6 units on the PDQ-Q4 scale
Standard Deviation 1.3
|
0.1 units on the PDQ-Q4 scale
Standard Deviation 1.1
|
|
Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Change at Month 6
|
0.6 units on the PDQ-Q4 scale
Standard Deviation 1.5
|
-0.1 units on the PDQ-Q4 scale
Standard Deviation 1.2
|
|
Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Change at Month 9
|
0.5 units on the PDQ-Q4 scale
Standard Deviation 1.5
|
-0.1 units on the PDQ-Q4 scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)Population: The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.
The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=191 Participants
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
n=196 Participants
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.
|
|---|---|---|
|
Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
Month 3
|
20 Participants
|
14 Participants
|
|
Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
Month 6
|
24 Participants
|
23 Participants
|
|
Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
Month 9
|
28 Participants
|
22 Participants
|
|
Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
Month 12
|
35 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)Population: The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.
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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=236 Participants
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
n=238 Participants
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.
|
|---|---|---|
|
Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
Month 6
|
144 Participants
|
126 Participants
|
|
Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
Month 9
|
148 Participants
|
127 Participants
|
|
Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
Month 12
|
147 Participants
|
120 Participants
|
|
Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
Month 3
|
148 Participants
|
138 Participants
|
PRIMARY outcome
Timeframe: 1 year (change in plaque volume measurement from baseline to month 12)Population: 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.
Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=73 Participants
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
n=65 Participants
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.
|
|---|---|---|
|
Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume
|
54 mm^3
Interval 12.0 to 97.0
|
14 mm^3
Interval -29.0 to 56.0
|
PRIMARY outcome
Timeframe: 1 year (QCT measurement of BMD change between baseline and month 12)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
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=110 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone
|
7.5 mg/cm^3
Interval 4.8 to 10.3
|
0.8 mg/cm^3
Interval -1.9 to 3.4
|
PRIMARY outcome
Timeframe: 1 year (change from baseline to month 6 and month 12)Population: Men, age 65 years or older with low testosterone and Age-Associated Memory Impairment (AAMI)
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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=247 Participants
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
n=246 Participants
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.
|
|---|---|---|
|
Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)
Baseline Score
|
14.0 percentage of change in test score
Interval 13.2 to 14.8
|
14.4 percentage of change in test score
Interval 13.6 to 15.2
|
|
Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)
Change at Month 6
|
1.1 percentage of change in test score
Interval -0.1 to 2.3
|
1.1 percentage of change in test score
Interval -0.1 to 2.3
|
|
Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)
Change at Month 12
|
1.3 percentage of change in test score
Interval 0.1 to 2.5
|
1.4 percentage of change in test score
Interval 0.3 to 2.6
|
PRIMARY outcome
Timeframe: 1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)Population: 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.
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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=27 Participants
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
n=35 Participants
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.
|
|---|---|---|
|
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
Month 3
|
6 Participants
|
4 Participants
|
|
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
Month 6
|
8 Participants
|
3 Participants
|
|
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
Month 9
|
15 Participants
|
2 Participants
|
|
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
Month 12
|
13 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=234 Participants
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
n=236 Participants
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.
|
|---|---|---|
|
Sexual Function Trial - Sexual Desire Domain
Baseline Score
|
11.9 Score on the DISF-M-II scale
Standard Deviation 6.7
|
11.6 Score on the DISF-M-II scale
Standard Deviation 6.6
|
|
Sexual Function Trial - Sexual Desire Domain
Change at Month 3
|
3.5 Score on the DISF-M-II scale
Standard Deviation 6.3
|
0.7 Score on the DISF-M-II scale
Standard Deviation 5.8
|
|
Sexual Function Trial - Sexual Desire Domain
Change at Month 6
|
3.5 Score on the DISF-M-II scale
Standard Deviation 6.0
|
0.8 Score on the DISF-M-II scale
Standard Deviation 5.6
|
|
Sexual Function Trial - Sexual Desire Domain
Change at Month 9
|
4.0 Score on the DISF-M-II scale
Standard Deviation 7.4
|
0.9 Score on the DISF-M-II scale
Standard Deviation 5.5
|
|
Sexual Function Trial - Sexual Desire Domain
Change at Month 12
|
2.6 Score on the DISF-M-II scale
Standard Deviation 6.5
|
0.0 Score on the DISF-M-II scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=234 Participants
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
n=236 Participants
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.
|
|---|---|---|
|
Sexual Function Trial - Erectile Function
Baseline Score
|
8.0 Score on the IIEF test scale
Standard Deviation 8.2
|
7.7 Score on the IIEF test scale
Standard Deviation 8.2
|
|
Sexual Function Trial - Erectile Function
Change at Month 3
|
3.4 Score on the IIEF test scale
Standard Deviation 6.1
|
1.0 Score on the IIEF test scale
Standard Deviation 5.3
|
|
Sexual Function Trial - Erectile Function
Change at Month 6
|
3.3 Score on the IIEF test scale
Standard Deviation 6.5
|
0.5 Score on the IIEF test scale
Standard Deviation 6.1
|
|
Sexual Function Trial - Erectile Function
Change at Month 9
|
3.4 Score on the IIEF test scale
Standard Deviation 6.9
|
0.5 Score on the IIEF test scale
Standard Deviation 7.1
|
|
Sexual Function Trial - Erectile Function
Change at Month 12
|
3.1 Score on the IIEF test scale
Standard Deviation 6.9
|
1.0 Score on the IIEF test scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=191 Participants
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
n=196 Participants
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.
|
|---|---|---|
|
Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Baseline Score
|
347.7 meters
Standard Deviation 69.1
|
344.9 meters
Standard Deviation 68.5
|
|
Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Change at Month 3
|
10.2 meters
Standard Deviation 35.8
|
4.6 meters
Standard Deviation 35.2
|
|
Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Change at Month 6
|
8.2 meters
Standard Deviation 41.5
|
7.8 meters
Standard Deviation 41.4
|
|
Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Change at Month 9
|
5.3 meters
Standard Deviation 50.3
|
3.2 meters
Standard Deviation 52.4
|
|
Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Change at Month 12
|
14.3 meters
Standard Deviation 45.9
|
5.5 meters
Standard Deviation 46.4
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)Population: The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.
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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=184 Participants
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
n=181 Participants
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.
|
|---|---|---|
|
Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
Month 3
|
77 Participants
|
59 Participants
|
|
Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
Month 6
|
72 Participants
|
73 Participants
|
|
Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
Month 9
|
77 Participants
|
60 Participants
|
|
Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
Month 12
|
66 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=184 Participants
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
n=181 Participants
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.
|
|---|---|---|
|
Physical Function Trial - PF 10 Overall Score
Baseline Score
|
65.4 Score on the PF-10 test scale
Standard Deviation 20.0
|
64.8 Score on the PF-10 test scale
Standard Deviation 21.3
|
|
Physical Function Trial - PF 10 Overall Score
Change at Month 3
|
5.6 Score on the PF-10 test scale
Standard Deviation 15.2
|
4.2 Score on the PF-10 test scale
Standard Deviation 13.7
|
|
Physical Function Trial - PF 10 Overall Score
Change at Month 6
|
6.5 Score on the PF-10 test scale
Standard Deviation 16.7
|
4.8 Score on the PF-10 test scale
Standard Deviation 17.0
|
|
Physical Function Trial - PF 10 Overall Score
Change at Month 9
|
5.9 Score on the PF-10 test scale
Standard Deviation 19.4
|
3.3 Score on the PF-10 test scale
Standard Deviation 18.9
|
|
Physical Function Trial - PF 10 Overall Score
Change at Month 12
|
5.8 Score on the PF-10 test scale
Standard Deviation 17.5
|
2.4 Score on the PF-10 test scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=236 Participants
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
n=238 Participants
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.
|
|---|---|---|
|
Vitality Trial - FACIT Fatigue Overall Score
Baseline Score
|
31.6 Score on the FACIT- Fatigue test scale
Standard Deviation 6.4
|
31.3 Score on the FACIT- Fatigue test scale
Standard Deviation 6.4
|
|
Vitality Trial - FACIT Fatigue Overall Score
Change at Month 3
|
7.8 Score on the FACIT- Fatigue test scale
Standard Deviation 8.4
|
7.2 Score on the FACIT- Fatigue test scale
Standard Deviation 8.8
|
|
Vitality Trial - FACIT Fatigue Overall Score
Change at Month 6
|
7.4 Score on the FACIT- Fatigue test scale
Standard Deviation 9.1
|
5.9 Score on the FACIT- Fatigue test scale
Standard Deviation 9.2
|
|
Vitality Trial - FACIT Fatigue Overall Score
Change at Month 9
|
8.6 Score on the FACIT- Fatigue test scale
Standard Deviation 9.1
|
7.2 Score on the FACIT- Fatigue test scale
Standard Deviation 9.2
|
|
Vitality Trial - FACIT Fatigue Overall Score
Change at Month 12
|
8.0 Score on the FACIT- Fatigue test scale
Standard Deviation 8.4
|
6.7 Score on the FACIT- Fatigue test scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=208 Participants
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
n=196 Participants
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.
|
|---|---|---|
|
Vitality Trial - SF-36 Score
Baseline Score
|
50.6 Score on the SF-36 vitality scale
Standard Deviation 13.8
|
49.4 Score on the SF-36 vitality scale
Standard Deviation 12.6
|
|
Vitality Trial - SF-36 Score
Change at Month 3
|
7.4 Score on the SF-36 vitality scale
Standard Deviation 13.6
|
5.9 Score on the SF-36 vitality scale
Standard Deviation 11.1
|
|
Vitality Trial - SF-36 Score
Change at Month 6
|
7.2 Score on the SF-36 vitality scale
Standard Deviation 14.6
|
4.5 Score on the SF-36 vitality scale
Standard Deviation 11.2
|
|
Vitality Trial - SF-36 Score
Change at Month 9
|
8.4 Score on the SF-36 vitality scale
Standard Deviation 14.4
|
5.7 Score on the SF-36 vitality scale
Standard Deviation 12.3
|
|
Vitality Trial - SF-36 Score
Change at Month 12
|
8.2 Score on the SF-36 vitality scale
Standard Deviation 15.3
|
6.1 Score on the SF-36 vitality scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=229 Participants
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
n=234 Participants
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.
|
|---|---|---|
|
Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Baseline Score
|
15.3 Score on the PANAS test scale
Standard Deviation 3.2
|
15.4 Score on the PANAS test scale
Standard Deviation 3.5
|
|
Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Change at Month 3
|
0.7 Score on the PANAS test scale
Standard Deviation 3.2
|
0.3 Score on the PANAS test scale
Standard Deviation 3.3
|
|
Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Change at Month 6
|
0.9 Score on the PANAS test scale
Standard Deviation 3.8
|
0.0 Score on the PANAS test scale
Standard Deviation 3.3
|
|
Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Change at Month 9
|
0.9 Score on the PANAS test scale
Standard Deviation 3.4
|
0.4 Score on the PANAS test scale
Standard Deviation 3.4
|
|
Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Change at Month 12
|
0.7 Score on the PANAS test scale
Standard Deviation 3.9
|
0.2 Score on the PANAS test scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=229 Participants
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
n=234 Participants
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.
|
|---|---|---|
|
Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Baseline Score
|
7.5 Score on the PANAS test scale
Standard Deviation 2.7
|
7.4 Score on the PANAS test scale
Standard Deviation 2.8
|
|
Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Change at Month 3
|
-0.2 Score on the PANAS test scale
Standard Deviation 2.5
|
0.3 Score on the PANAS test scale
Standard Deviation 2.4
|
|
Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Change at Month 6
|
-0.4 Score on the PANAS test scale
Standard Deviation 2.4
|
0.4 Score on the PANAS test scale
Standard Deviation 2.6
|
|
Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Change at Month 9
|
-0.2 Score on the PANAS test scale
Standard Deviation 2.3
|
-0.1 Score on the PANAS test scale
Standard Deviation 2.6
|
|
Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Change at Month 12
|
-0.6 Score on the PANAS test scale
Standard Deviation 2.1
|
-0.1 Score on the PANAS test scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 3, 6, 9 and 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=230 Participants
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
n=234 Participants
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.
|
|---|---|---|
|
Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Baseline Score
|
6.6 Score on the PHQ-9 test scale
Standard Deviation 4.0
|
6.6 Score on the PHQ-9 test scale
Standard Deviation 4.0
|
|
Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Change at Month 3
|
-1.3 Score on the PHQ-9 test scale
Standard Deviation 3.8
|
-0.8 Score on the PHQ-9 test scale
Standard Deviation 3.5
|
|
Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Change at Month 6
|
-1.7 Score on the PHQ-9 test scale
Standard Deviation 3.8
|
-0.5 Score on the PHQ-9 test scale
Standard Deviation 3.7
|
|
Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Change at Month 9
|
-1.9 Score on the PHQ-9 test scale
Standard Deviation 4.0
|
-1.2 Score on the PHQ-9 test scale
Standard Deviation 4.2
|
|
Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Change at Month 12
|
-1.8 Score on the PHQ-9 test scale
Standard Deviation 3.7
|
-1.1 Score on the PHQ-9 test scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 12)Total plaque volume,mm3 measured by coronary computed tomographic angiography
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=73 Participants
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
n=65 Participants
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.
|
|---|---|---|
|
Cardiovascular Trial - Total Plaque Volume Change From Baseline
|
75 mm^3
Interval 22.0 to 128.0
|
28 mm^3
Interval -24.0 to 81.0
|
SECONDARY outcome
Timeframe: 1 year (change from baseline to month 12)Population: All participants with measurements of both baseline and 12-month assessments were included in the analysis.
Coronary artery calcium score in Agatston units (range of 0 to \>400 Agatston units), with higher values indicating more severe atherosclerosis).
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=73 Participants
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
n=65 Participants
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.
|
|---|---|---|
|
Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline
|
64 Agatston units
Interval -19.0 to 146.0
|
91 Agatston units
Interval 7.0 to 174.0
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=110 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)
|
4.0 percentage of change
Interval 2.9 to 5.2
|
1.1 percentage of change
Interval 0.0 to 2.2
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=110 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)
|
5.5 percentage of change
Interval 4.0 to 6.9
|
1.2 percentage of change
Interval -0.2 to 2.6
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=103 Participants
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
n=88 Participants
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.
|
|---|---|---|
|
Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)
|
1.6 percentage of change
Interval 0.8 to 2.4
|
0.1 percentage of change
Interval -0.6 to 0.9
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=103 Participants
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
n=88 Participants
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.
|
|---|---|---|
|
Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)
|
1.6 percentage of change
Interval 0.9 to 2.3
|
0.7 percentage of change
Interval 0.0 to 1.4
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=103 Participants
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
n=88 Participants
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.
|
|---|---|---|
|
Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)
|
1.7 percentage of change
Interval 1.0 to 2.4
|
0.4 percentage of change
Interval -0.2 to 1.1
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=110 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N
|
9.0 percentage of change
Interval 6.4 to 11.6
|
1.9 percentage of change
Interval -0.6 to 4.4
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=110 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N
|
10.8 percentage of change
Interval 7.4 to 14.3
|
2.4 percentage of change
Interval -1.0 to 5.7
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=110 Participants
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
n=97 Participants
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.
|
|---|---|---|
|
Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N
|
7.2 percentage of change
Interval 5.2 to 9.2
|
1.5 percentage of change
Interval -0.5 to 3.4
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=103 Participants
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
n=88 Participants
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.
|
|---|---|---|
|
Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N
|
2.5 percentage of change
Interval 1.4 to 3.5
|
0.6 percentage of change
Interval -0.4 to 1.7
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=103 Participants
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
n=88 Participants
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.
|
|---|---|---|
|
Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N
|
1.5 percentage of change
Interval 0.5 to 2.5
|
0.5 percentage of change
Interval -0.5 to 1.5
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=103 Participants
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
n=88 Participants
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.
|
|---|---|---|
|
Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N
|
1.4 percentage of change
Interval 0.7 to 2.0
|
0.4 percentage of change
Interval -0.3 to 1.0
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=109 Participants
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
n=101 Participants
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.
|
|---|---|---|
|
Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)
|
3.3 percentage of change
Interval 2.01 to 4.56
|
2.1 percentage of change
Interval 0.87 to 3.36
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=108 Participants
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
n=100 Participants
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.
|
|---|---|---|
|
Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)
|
1.2 percentage of change
Interval 0.19 to 2.17
|
0.5 percentage of change
Interval -0.45 to 1.46
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=108 Participants
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
n=100 Participants
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.
|
|---|---|---|
|
Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)
|
1.5 percentage of change
Interval 0.02 to 2.97
|
0.9 percentage of change
Interval -0.49 to 2.35
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 6 and month 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=246 Participants
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
n=246 Participants
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.
|
|---|---|---|
|
Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)
Baseline Score
|
-8.2 Score on the BVRT test scale
Interval -8.6 to -7.8
|
-8.2 Score on the BVRT test scale
Interval -8.6 to -7.8
|
|
Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)
Change at Month 6
|
0.2 Score on the BVRT test scale
Interval -0.4 to 0.9
|
0.3 Score on the BVRT test scale
Interval -0.3 to 1.0
|
|
Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)
Change at Month 12
|
0.3 Score on the BVRT test scale
Interval -0.4 to 0.9
|
0.7 Score on the BVRT test scale
Interval 0.0 to 1.4
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 6 to month 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=245 Participants
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
n=243 Participants
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.
|
|---|---|---|
|
Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)
Baseline Score
|
28.7 Score on the CRT test scale
Interval 26.9 to 30.5
|
30.0 Score on the CRT test scale
Interval 28.1 to 31.8
|
|
Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)
Change at Month 6
|
0.6 Score on the CRT test scale
Interval -1.9 to
|
0.2 Score on the CRT test scale
Interval -2.3 to 2.7
|
|
Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)
Change at Month 12
|
0.6 Score on the CRT test scale
Interval -1.8 to 3.1
|
1.2 Score on the CRT test scale
Interval -1.3 to 3.7
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 6 to month 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=245 Participants
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
n=245 Participants
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.
|
|---|---|---|
|
Cognitive Function Trial - Executive Function - Trail Making Test B - A
Baseline Score
|
86.4 Score on the Trail Making Test scale
Interval 78.3 to 94.6
|
76.7 Score on the Trail Making Test scale
Interval 69.9 to 83.5
|
|
Cognitive Function Trial - Executive Function - Trail Making Test B - A
Change at Month 6
|
-2.1 Score on the Trail Making Test scale
Interval -12.4 to 8.2
|
1.8 Score on the Trail Making Test scale
Interval -8.6 to 12.2
|
|
Cognitive Function Trial - Executive Function - Trail Making Test B - A
Change at Month 12
|
-0.0 Score on the Trail Making Test scale
Interval -10.3 to 10.3
|
7.1 Score on the Trail Making Test scale
Interval -3.3 to 17.5
|
SECONDARY outcome
Timeframe: 1 year (baseline to month 12)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.
Outcome measures
| Measure |
AndroGel® (Testosterone Gel)
n=27 Participants
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
n=35 Participants
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.
|
|---|---|---|
|
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)
|
0.9 proportion of participants
Standard Deviation 1.4
|
0.2 proportion of participants
Standard Deviation 0.8
|
Adverse Events
AndroGel® (Testosterone Gel)
Serious events: 183 serious events
Other events: 343 other events
Deaths: 0 deaths
Placebo Gel
Serious events: 176 serious events
Other events: 341 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AndroGel® (Testosterone Gel)
n=394 participants at risk
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
n=394 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.51%
2/394 • Number of events 2 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
0.51%
2/394 • Number of events 2 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Cardiac disorders
Cardiac disorders
|
8.9%
35/394 • Number of events 38 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
8.6%
34/394 • Number of events 42 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.5%
10/394 • Number of events 10 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
1.8%
7/394 • Number of events 8 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.0%
4/394 • Number of events 4 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
0.51%
2/394 • Number of events 3 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Infections and infestations
Infections and infestations
|
7.4%
29/394 • Number of events 34 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
5.3%
21/394 • Number of events 25 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.3%
9/394 • Number of events 11 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
2.8%
11/394 • Number of events 14 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
1.0%
4/394 • Number of events 4 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
5.6%
22/394 • Number of events 24 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
4.8%
19/394 • Number of events 22 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
3.8%
15/394 • Number of events 16 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
3.0%
12/394 • Number of events 14 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Nervous system disorders
Nervous system disorders
|
4.1%
16/394 • Number of events 17 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
5.6%
22/394 • Number of events 24 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.76%
3/394 • Number of events 5 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.0%
4/394 • Number of events 5 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders
|
2.3%
9/394 • Number of events 10 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
4.3%
17/394 • Number of events 22 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
0.25%
1/394 • Number of events 1 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Vascular disorders
Vascular disorders
|
2.5%
10/394 • Number of events 12 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
1.8%
7/394 • Number of events 7 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
General disorders
General disorders
|
3.0%
12/394 • Number of events 13 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
3.6%
14/394 • Number of events 15 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
Other adverse events
| Measure |
AndroGel® (Testosterone Gel)
n=394 participants at risk
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
n=394 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
11.4%
45/394 • Number of events 82 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
11.4%
45/394 • Number of events 88 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Infections and infestations
Infections and infestations
|
38.6%
152/394 • Number of events 221 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
36.8%
145/394 • Number of events 220 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Eye disorders
Eye disorders
|
5.8%
23/394 • Number of events 27 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
6.9%
27/394 • Number of events 36 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
16.5%
65/394 • Number of events 99 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
18.0%
71/394 • Number of events 116 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
General disorders
General disorders and administration site conditions
|
18.8%
74/394 • Number of events 115 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
19.0%
75/394 • Number of events 99 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Injury, poisoning and procedural complications
Injury poisoning and procedural complications
|
22.1%
87/394 • Number of events 143 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
22.6%
89/394 • Number of events 160 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Investigations
Investigations
|
11.4%
45/394 • Number of events 59 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
9.4%
37/394 • Number of events 54 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
6.1%
24/394 • Number of events 31 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
7.4%
29/394 • Number of events 34 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
36.8%
145/394 • Number of events 272 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
39.3%
155/394 • Number of events 293 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
|
7.1%
28/394 • Number of events 35 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
5.6%
22/394 • Number of events 27 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Nervous system disorders
Nervous system disorders
|
19.0%
75/394 • Number of events 101 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
19.8%
78/394 • Number of events 107 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Psychiatric disorders
Psychiatric disorders
|
6.6%
26/394 • Number of events 41 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
6.9%
27/394 • Number of events 37 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
10.9%
43/394 • Number of events 59 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
10.7%
42/394 • Number of events 53 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
12.4%
49/394 • Number of events 63 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
4.8%
19/394 • Number of events 22 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
18.8%
74/394 • Number of events 110 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
17.0%
67/394 • Number of events 106 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
22.3%
88/394 • Number of events 156 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
13.2%
52/394 • Number of events 75 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
9.1%
36/394 • Number of events 55 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
7.9%
31/394 • Number of events 43 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
|
Vascular disorders
Vascular disorders
|
8.4%
33/394 • Number of events 42 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
8.6%
34/394 • Number of events 43 • Adverse events were identified during study visits in the First (Treatment) Year, and by phone interview during the Second (Observation) Year.
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.
|
Additional Information
Peter J. Snyder, MD
University of Pennsylvania, Perelman School of Medicine
Phone: 215-898-0208
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place