Brief Summary
The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States.
The primary specific aims are to test the hypotheses that testosterone treatment of elderly men whose serum testosterone concentrations are unequivocally low - and who have symptoms and objectively measured abnormalities in at least one of five areas that could be due to low testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in more favorable changes in those abnormalities than placebo treatment.
Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials.
* The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo.
* The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment.
A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.
The primary specific aims are to test the hypotheses that testosterone treatment of elderly men whose serum testosterone concentrations are unequivocally low - and who have symptoms and objectively measured abnormalities in at least one of five areas that could be due to low testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in more favorable changes in those abnormalities than placebo treatment.
Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials.
* The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo.
* The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment.
A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.
Brief Title
The Testosterone Trials in Older Men
Detailed Description
As men get older, they experience many conditions, often together, that eventually result in the inability to perform many activities of daily living, an increased propensity to fall, and decreased independence. These conditions include mobility disability and low vitality. Elderly men also experience increased anemia, metabolic syndrome, decreased sexual function and memory impairment. These conditions likely have multiple causes, but one cause that could contribute to all of them is a low serum testosterone concentration. When young hypogonadal men are treated with testosterone, they experience improvements in sexual function, muscle mass and strength, bone mineral density, sense of well being, and anemia. However, the benefits of testosterone therapy in older men with age-related decline in testosterone concentration are not known and are the subject of this investigation.
Participants will be treated with testosterone or placebo gel for 1 year. The dose will be adjusted in a blinded fashion to achieve a target T level range. Participants will be followed for one additional year following the treatment phase to assess adverse events.
* Men participating in the Cardiovascular Trial will be assessed for changes in atherosclerotic plaque burden from 0 to 12 months.
* Men participating in the Bone Trial will be assessed by QCT of the spine and hip, DXA of the spine and hip and clinical fractures at 0 and 12 months.
* Men participating in the PK Study will attend 3 additional study visits for blood draws at the time of the 4-month assessment.
Participants will be treated with testosterone or placebo gel for 1 year. The dose will be adjusted in a blinded fashion to achieve a target T level range. Participants will be followed for one additional year following the treatment phase to assess adverse events.
* Men participating in the Cardiovascular Trial will be assessed for changes in atherosclerotic plaque burden from 0 to 12 months.
* Men participating in the Bone Trial will be assessed by QCT of the spine and hip, DXA of the spine and hip and clinical fractures at 0 and 12 months.
* Men participating in the PK Study will attend 3 additional study visits for blood draws at the time of the 4-month assessment.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Andropause
Eligibility Criteria
Inclusion Criteria:
* Men greater than or equal to 65 years old
* Total serum testosterone concentration \< 275 and \< 300 ng/dL at 7 -10 AM at each of two screening visits
Exclusion Criteria:
* Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule or, by the Prostate Cancer Risk Calculator, a \>35% risk of having overall prostate cancer or \>7% risk of having high grade prostate cancer
* Severe lower urinary tract symptoms (score of \> 19) by the International Prostate Symptom Score questionnaire
* Hemoglobin \<10 g/dL or \>16.0 g/dL
* Sleep apnea, diagnosed but untreated
* Alcohol or substance abuse within the past year (based on self report)
* Angina not controlled by treatment
* NYHA class III or IV congestive heart failure
* Myocardial infarction within the previous 3 months before entry
* Stroke within the previous 3 months before entry
* Severe pulmonary disease that precludes physical function tests
* Serum creatinine \>2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c \>8.5%, TSH \> 7.5mIU/L
* Diagnosis or treatment for cancer within the past 3 years, with the exception of nonmelanotic skin cancer
* Body mass index (BMI) \>37 kg/m2
* Mini Mental State Exam (MMSE) Score \<24
* Major psychiatric disorders, including major depression (PHQ-9 score \> 14), mania, hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated, unstable, have resulted in hospitalization or medication change within the previous three months, or would result in inability to complete the trial efficacy instruments. Subjects whose disorders have been stable while being treated for more than three months are eligible.
* Use of the following medications within the previous three months:
* drugs that affect serum testosterone concentration
* rhGH or megestrol acetate
* introduction of anti-depressant medication
* daily use of prednisone for more than two weeks
* Opiate use within the past three months
* Skin conditions at the testosterone gel application site, such as ulcer, erosion, lichenification, inflammation, or crust, or generalized skin conditions such as psoriasis or eczema that might affect testosterone absorption or tolerability of the testosterone gel
* Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone gel
Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is determined that they are eligible based on the specific exclusion criteria.
* Men greater than or equal to 65 years old
* Total serum testosterone concentration \< 275 and \< 300 ng/dL at 7 -10 AM at each of two screening visits
Exclusion Criteria:
* Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule or, by the Prostate Cancer Risk Calculator, a \>35% risk of having overall prostate cancer or \>7% risk of having high grade prostate cancer
* Severe lower urinary tract symptoms (score of \> 19) by the International Prostate Symptom Score questionnaire
* Hemoglobin \<10 g/dL or \>16.0 g/dL
* Sleep apnea, diagnosed but untreated
* Alcohol or substance abuse within the past year (based on self report)
* Angina not controlled by treatment
* NYHA class III or IV congestive heart failure
* Myocardial infarction within the previous 3 months before entry
* Stroke within the previous 3 months before entry
* Severe pulmonary disease that precludes physical function tests
* Serum creatinine \>2.2 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c \>8.5%, TSH \> 7.5mIU/L
* Diagnosis or treatment for cancer within the past 3 years, with the exception of nonmelanotic skin cancer
* Body mass index (BMI) \>37 kg/m2
* Mini Mental State Exam (MMSE) Score \<24
* Major psychiatric disorders, including major depression (PHQ-9 score \> 14), mania, hypomania, psychosis, schizophrenia or schizoaffective disorders, that are untreated, unstable, have resulted in hospitalization or medication change within the previous three months, or would result in inability to complete the trial efficacy instruments. Subjects whose disorders have been stable while being treated for more than three months are eligible.
* Use of the following medications within the previous three months:
* drugs that affect serum testosterone concentration
* rhGH or megestrol acetate
* introduction of anti-depressant medication
* daily use of prednisone for more than two weeks
* Opiate use within the past three months
* Skin conditions at the testosterone gel application site, such as ulcer, erosion, lichenification, inflammation, or crust, or generalized skin conditions such as psoriasis or eczema that might affect testosterone absorption or tolerability of the testosterone gel
* Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone gel
Participants in the T Trial may also enroll in the Cardiovascular and Bone Trials if it is determined that they are eligible based on the specific exclusion criteria.
Inclusion Criteria
Inclusion Criteria:
* Men greater than or equal to 65 years old
* Total serum testosterone concentration \< 275 and \< 300 ng/dL at 7 -10 AM at each of two screening visits
* Men greater than or equal to 65 years old
* Total serum testosterone concentration \< 275 and \< 300 ng/dL at 7 -10 AM at each of two screening visits
Gender
Male
Gender Based
false
Keywords
Testosterone
Mobility disability
Decreased libido
Age associated memory impairment
Low vitality
Anemia
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT00799617
Org Class
Other
Org Full Name
University of Pennsylvania
Org Study Id
U01AG030644
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men
Primary Outcomes
Outcome Description
Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12.
Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.
The change is measured form the baseline value to Month 12.
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 Measure
Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Description
The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.
Outcome Measure
Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)
Outcome Time Frame
1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)
Outcome Description
The number of participants whose score on the FACIT-Fatigue scale increased by at least 4 points.
Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.
Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.
Outcome Measure
Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)
Outcome Time Frame
1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)
Outcome Description
Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12
Outcome Measure
Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume
Outcome Time Frame
1 year (change in plaque volume measurement from baseline to month 12)
Outcome Description
Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12
Outcome Measure
Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone
Outcome Time Frame
1 year (QCT measurement of BMD change between baseline and month 12)
Outcome Description
Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12.
The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (\<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR.
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 Measure
Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)
Outcome Time Frame
1 year (change from baseline to month 6 and month 12)
Outcome Description
Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline.
Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline.
Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline.
Outcome Measure
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia
Outcome Time Frame
1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)
Secondary Ids
Secondary Id
R01AG037679
Secondary Outcomes
Outcome Description
Baseline score and the changes in the score of the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II), from baseline to Month 12.
Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire.
Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire.
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Sexual Function Trial - Sexual Desire Domain
Outcome Description
Baseline score and the change in score on the International Index of Erectile Function (IIEF) from baseline to Month 12.
Scores on the IIEF range from 0-30, with higher scores indicating better function.
Scores on the IIEF range from 0-30, with higher scores indicating better function.
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Sexual Function Trial - Erectile Function
Outcome Description
Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters
Outcome Description
The number of participants whose score on the physical-function domain (PF-10; range, 0 to 100, with higher scores indicating better function) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) increased by at least 8 points from baseline to Month 12.
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)
Outcome Description
Baseline score and the change in score on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short Form Health Survey range from 0 to 100, with higher scores indicating better function.
Scores were measured as the change from baseline to Month 12.
Scores were measured as the change from baseline to Month 12.
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Physical Function Trial - PF 10 Overall Score
Outcome Description
Baseline score and change in the FACIT- Fatigue score from baseline to Month 12. Scores on the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Vitality Trial - FACIT Fatigue Overall Score
Outcome Description
Baseline score and change in the SF-36 Vitality Score from baseline to Month 12 Scores on the vitality scale of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating less fatigue.
Outcome Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Vitality Trial - SF-36 Score
Outcome Description
Baseline score and change in the total positive affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.
Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect.
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 Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.
Outcome Description
Baseline score and change in the total negative affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.
Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect.
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 Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12
Outcome Description
Baseline score and change in score in the Patient Health Questionnaire 9 (PHQ-9) from baseline to Month 12.
Scores on the Patient Health Questionnaire 9 (PHQ-9) depression scale range from 0 to 27, with higher scores indicating greater intensity of depressive symptoms.
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 Time Frame
1 year (change from baseline to month 3, 6, 9 and 12)
Outcome Measure
Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score
Outcome Description
Total plaque volume,mm3 measured by coronary computed tomographic angiography
Outcome Time Frame
1 year (change from baseline to month 12)
Outcome Measure
Cardiovascular Trial - Total Plaque Volume Change From Baseline
Outcome Description
Coronary artery calcium score in Agatston units (range of 0 to \>400 Agatston units), with higher values indicating more severe atherosclerosis).
Outcome Time Frame
1 year (change from baseline to month 12)
Outcome Measure
Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline
Outcome Description
Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)
Outcome Description
Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)
Outcome Description
Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)
Outcome Description
Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)
Outcome Description
Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)
Outcome Description
Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N
Outcome Description
Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N
Outcome Description
Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N
Outcome Description
Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N
Outcome Description
Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N
Outcome Description
Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N
Outcome Description
Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)
Outcome Description
Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)
Outcome Description
Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)
Outcome Description
Baseline score and mean change in score in the Visual Memory Using the Benton Visual Retention Test (BVRT) from baseline, Month 6 and Month 12.
The BVRT measures short term visual memory and visuo-constructional abilities and was administered and scored according to standard procedures. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score was the total number of figures with errors and ranged from 0 to 26. Scores were inverted to 0 to -26 so that higher scores would reflect better performance.
Change in BVRT scores from baseline are treated as continuous and compared between AAMI Androgel and placebo subjects using linear random effects models adjusting for balancing factors as described in the primary analysis.
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 Time Frame
1 year (baseline to month 6 and month 12)
Outcome Measure
Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)
Outcome Description
Baseline score and change in score in the Spatial Ability Using the Card Rotation Test at baseline, Month 6 and Month 12.
Change in performance on the Card Rotations Test will be analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version. The test consists of a series of 10 primary figures, each of which has 8 corresponding secondary figures. Subjects are asked to determine which of the secondary figures is the same as the corresponding primary figure, and the score is taken as the number of figures answered correctly minus the number of figures answered incorrectly.
The maximum score is 80 for subjects who answer all items correctly.
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 Time Frame
1 year (baseline to month 6 to month 12)
Outcome Measure
Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)
Outcome Description
Baseline score and change in score in Executive Function as Measured by Trail-Making Test (TMT) B - A, at baseline, Month 6 and Month 12.
Change in performance on the Trail Making Test was analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version.
Participants are required to connect a set of numbers (Part A) or alternating letters and numbers (Part B) in sequential order. The score for each part is the total time (in seconds) to complete both parts. The outcome analyzed will be the total time for Trails B minus the total time for Trails A to provide a measure of working memory, adjusted for attention and processing speed. Higher scores reflect lower executive function.
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 Time Frame
1 year (baseline to month 6 to month 12)
Outcome Measure
Cognitive Function Trial - Executive Function - Trail Making Test B - A
Outcome Description
Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 gm/dL from baseline.
Values are means (SDs) for continuous outcomes.
Values are means (SDs) for continuous outcomes.
Outcome Time Frame
1 year (baseline to month 12)
Outcome Measure
Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jill Crandall
Investigator Email
jill.crandall@einsteinmed.org
Investigator Phone
Categories Mesh Debug
Blood Disorders --- ANEMIA
Blood & Bone Marrow Cancers --- ANEMIA
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
MeSH Terms
ANEMIA
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
TESTOSTERONE
COUNTERFEIT DRUGS
ANDROSTENOLS
ANDROSTENES
ANDROSTANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
TESTOSTERONE CONGENERS
GONADAL STEROID HORMONES
GONADAL HORMONES
HORMONES
HORMONES, HORMONE SUBSTITUTES, AND HORMONE ANTAGONISTS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS