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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG037679 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AndroGel® (testosterone gel) | Active Comparator | The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day. Participants will apply AndroGel once daily to the shoulders, abdomen or upper arms. The serum testosterone concentration will be measured monthly for the first three months, then at months 6, 9 and 12. If the testosterone concentration is not between 500 and 800 ng/dL at any time point, the dose will be either increased by increments of 1.25-2.5 g/day, up to a maximum of 15 g/day or decreased by increments of 1.25-3.75 ng/day. Participants will be taught how to apply the gel and they will be provided with written instructions and precautions. This information will be reviewed at each contact and visit. |
|
| Placebo gel | Placebo Comparator | 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. Participants will be taught how to apply the gel and they will be provided with written instructions and precautions. This information will be reviewed at each contact and visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AndroGel® (testosterone gel) | Drug | Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%) | The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters. | 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12) |
| Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%) | 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. | 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12) |
| Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume | Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12 | 1 year (change in plaque volume measurement from baseline to month 12) |
| Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Function Trial - Sexual Desire Domain | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Snyder, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38224135 | Derived | Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2. | |
| 35041751 | Derived | Stephens-Shields AJ, Snyder PJ, Ellenberg SS, Taylor L, Bhasin S. Relation of Testosterone, Dihydrotestosterone, and Estradiol With Changes in Outcomes Measures in the Testosterone Trials. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1257-1269. doi: 10.1210/clinem/dgac028. |
| Label | URL |
|---|---|
| Find out more information about The Testosterone Trial and the list of participating clinical sites. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Testosterone Trial |
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| Sexual Funtion Trial |
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| Physical Function Trial |
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| Vitality Trial |
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| Cardiovascular Trial |
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| Bone Trial |
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| Cognitive Function Trial |
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| Anemia Trial |
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Two participants were randomized in error, one in each arm of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Men in the trial were 65 years of age or older. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 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. | Posted | Mean | Standard Deviation | units on the PDQ-Q4 scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter J. Snyder, MD | University of Pennsylvania, Perelman School of Medicine | 215-898-0208 | pjsnyder@upenn.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Abbott | INDUSTRY |
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| Placebo | Drug | Testosterone levels will be measured at regular intervals. |
|
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
| 1 year (QCT measurement of BMD change between baseline and month 12) |
| Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) | 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. | 1 year (change from baseline to month 6 and month 12) |
| Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia | 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. | 1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12) |
| Sexual Function Trial - Erectile Function | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters | Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12 | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%) | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Physical Function Trial - PF 10 Overall Score | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Vitality Trial - FACIT Fatigue Overall Score | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Vitality Trial - SF-36 Score | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score | 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. | 1 year (change from baseline to month 3, 6, 9 and 12) |
| Cardiovascular Trial - Total Plaque Volume Change From Baseline | Total plaque volume,mm3 measured by coronary computed tomographic angiography | 1 year (change from baseline to month 12) |
| Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline | Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis). | 1 year (change from baseline to month 12) |
| Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT) | Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT) | Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT) | Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT) | Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT) | Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N | Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N | Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N | Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N | Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N | Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N | Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA) | Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA) | Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) | Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | 1 year (baseline to month 12) |
| Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT) | 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. | 1 year (baseline to month 6 and month 12) |
| Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT) | 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. | 1 year (baseline to month 6 to month 12) |
| Cognitive Function Trial - Executive Function - Trail Making Test B - A | 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. | 1 year (baseline to month 6 to month 12) |
| Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous) | 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. | 1 year (baseline to month 12) |
| La Jolla |
| California |
| 92093 |
| United States |
| Center for Men's Health LA BioMed at Harbor-UCLA Medical Center | Torrance | California | 90501 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Northwestern University | Chicago | Illinois | 60208 | United States |
| Boston University | Boston | Massachusetts | 02215 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| Baylor College of Medicine | Houston | Texas | 76798 | United States |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| 32785689 | Derived | Artz AS, Stephens-Shields AJ, Bhasin S, Ellenberg SS, Cohen HJ, Snyder PJ. Markers of Iron Flux during Testosterone-Mediated Erythropoiesis in Older Men with Unexplained or Iron-Deficiency Anemia. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3396-403. doi: 10.1210/clinem/dgaa521. |
| 31784747 | Derived | Shaikh K, Ellenberg SS, Nakanishi R, Snyder PJ, Lee J, Wenger NK, Lewis CE, Swerdloff RS, Preston P, Hamal S, Stephens-Sheilds A, Bhasin S, Cherukuri L, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Matsumoto AM, Molich ME, Alla VM, Birudaraju D, Nezarat N, Rai K, Almeida S, Roy SK, Sheikh M, Trad G, Budoff MJ. Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2142-9. doi: 10.1210/clinem/dgz242. |
| 30366567 | Derived | Bhasin S, Ellenberg SS, Storer TW, Basaria S, Pahor M, Stephens-Shields AJ, Cauley JA, Ensrud KE, Farrar JT, Cella D, Matsumoto AM, Cunningham GR, Swerdloff RS, Wang C, Lewis CE, Molitch ME, Barrett-Connor E, Crandall JP, Hou X, Preston P, Cifelli D, Snyder PJ, Gill TM. Effect of testosterone replacement on measures of mobility in older men with mobility limitation and low testosterone concentrations: secondary analyses of the Testosterone Trials. Lancet Diabetes Endocrinol. 2018 Nov;6(11):879-890. doi: 10.1016/S2213-8587(18)30171-2. |
| 29253154 | Derived | Mohler ER 3rd, Ellenberg SS, Lewis CE, Wenger NK, Budoff MJ, Lewis MR, Barrett-Connor E, Swerdloff RS, Stephens-Shields A, Bhasin S, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Gill TM, Matsumoto AM, Molitch ME, Pahor M, Preston PE, Hou X, Cifelli D, Snyder PJ. The Effect of Testosterone on Cardiovascular Biomarkers in the Testosterone Trials. J Clin Endocrinol Metab. 2018 Feb 1;103(2):681-688. doi: 10.1210/jc.2017-02243. |
| 28241356 | Derived | Resnick SM, Matsumoto AM, Stephens-Shields AJ, Ellenberg SS, Gill TM, Shumaker SA, Pleasants DD, Barrett-Connor E, Bhasin S, Cauley JA, Cella D, Crandall JP, Cunningham GR, Ensrud KE, Farrar JT, Lewis CE, Molitch ME, Pahor M, Swerdloff RS, Cifelli D, Anton S, Basaria S, Diem SJ, Wang C, Hou X, Snyder PJ. Testosterone Treatment and Cognitive Function in Older Men With Low Testosterone and Age-Associated Memory Impairment. JAMA. 2017 Feb 21;317(7):717-727. doi: 10.1001/jama.2016.21044. |
| 28241355 | Derived | Budoff MJ, Ellenberg SS, Lewis CE, Mohler ER 3rd, Wenger NK, Bhasin S, Barrett-Connor E, Swerdloff RS, Stephens-Shields A, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Gill TM, Matsumoto AM, Molitch ME, Nakanishi R, Nezarat N, Matsumoto S, Hou X, Basaria S, Diem SJ, Wang C, Cifelli D, Snyder PJ. Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone. JAMA. 2017 Feb 21;317(7):708-716. doi: 10.1001/jama.2016.21043. |
| 28241237 | Derived | Roy CN, Snyder PJ, Stephens-Shields AJ, Artz AS, Bhasin S, Cohen HJ, Farrar JT, Gill TM, Zeldow B, Cella D, Barrett-Connor E, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Lewis CE, Matsumoto AM, Molitch ME, Pahor M, Swerdloff RS, Cifelli D, Hou X, Resnick SM, Walston JD, Anton S, Basaria S, Diem SJ, Wang C, Schrier SL, Ellenberg SS. Association of Testosterone Levels With Anemia in Older Men: A Controlled Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):480-490. doi: 10.1001/jamainternmed.2016.9540. |
| 28241231 | Derived | Snyder PJ, Kopperdahl DL, Stephens-Shields AJ, Ellenberg SS, Cauley JA, Ensrud KE, Lewis CE, Barrett-Connor E, Schwartz AV, Lee DC, Bhasin S, Cunningham GR, Gill TM, Matsumoto AM, Swerdloff RS, Basaria S, Diem SJ, Wang C, Hou X, Cifelli D, Dougar D, Zeldow B, Bauer DC, Keaveny TM. Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men With Low Testosterone: A Controlled Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):471-479. doi: 10.1001/jamainternmed.2016.9539. |
| 27355400 | Derived | Cunningham GR, Stephens-Shields AJ, Rosen RC, Wang C, Bhasin S, Matsumoto AM, Parsons JK, Gill TM, Molitch ME, Farrar JT, Cella D, Barrett-Connor E, Cauley JA, Cifelli D, Crandall JP, Ensrud KE, Gallagher L, Zeldow B, Lewis CE, Pahor M, Swerdloff RS, Hou X, Anton S, Basaria S, Diem SJ, Tabatabaie V, Ellenberg SS, Snyder PJ. Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels. J Clin Endocrinol Metab. 2016 Aug;101(8):3096-104. doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29. |
| 26886521 | Derived | Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar JT, Cella D, Rosen RC, Pahor M, Crandall JP, Molitch ME, Cifelli D, Dougar D, Fluharty L, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS; Testosterone Trials Investigators. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119. |
| 26554661 | Derived | Abd Alamir M, Ellenberg SS, Swerdloff RS, Wenger NK, Mohler ER 3rd, Lewis CE, Barrett-Conner E, Nakanishi R, Darabian S, Alani A, Matsumoto S, Nezarat N, Snyder PJ, Budoff MJ. The Cardiovascular Trial of the Testosterone Trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis. Coron Artery Dis. 2016 Mar;27(2):95-103. doi: 10.1097/MCA.0000000000000321. |
| 25548978 | Derived | Cunningham GR, Stephens-Shields AJ, Rosen RC, Wang C, Ellenberg SS, Matsumoto AM, Bhasin S, Molitch ME, Farrar JT, Cella D, Barrett-Connor E, Cauley JA, Cifelli D, Crandall JP, Ensrud KE, Fluharty L, Gill TM, Lewis CE, Pahor M, Resnick SM, Storer TW, Swerdloff RS, Anton S, Basaria S, Diem S, Tabatabaie V, Hou X, Snyder PJ. Association of sex hormones with sexual function, vitality, and physical function of symptomatic older men with low testosterone levels at baseline in the testosterone trials. J Clin Endocrinol Metab. 2015 Mar;100(3):1146-55. doi: 10.1210/jc.2014-3818. Epub 2014 Dec 30. |
| 21761342 | Derived | Meng J, Mostaghel EA, Vakar-Lopez F, Montgomery B, True L, Nelson PS. Testosterone regulates tight junction proteins and influences prostatic autoimmune responses. Horm Cancer. 2011 Jun;2(3):145-56. doi: 10.1007/s12672-010-0063-1. |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
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.
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | All of the participants in this trial of testosterone gel use are men. | 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. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%) | The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters. | The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete. | Posted | Count of Participants | Participants | 1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12) |
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| Primary | Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%) | 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. | The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete. | Posted | Count of Participants | Participants | 1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12) |
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| Primary | Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume | Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12 | 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. | Posted | Mean | 95% Confidence Interval | mm^3 | 1 year (change in plaque volume measurement from baseline to month 12) |
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| Primary | Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone | 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 | Posted | Mean | 95% Confidence Interval | mg/cm^3 | 1 year (QCT measurement of BMD change between baseline and month 12) |
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| Primary | Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) | 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. | Men, age 65 years or older with low testosterone and Age-Associated Memory Impairment (AAMI) | Posted | Mean | 95% Confidence Interval | percentage of change in test score | 1 year (change from baseline to month 6 and month 12) |
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| Primary | Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia | 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. | 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. | Posted | Count of Participants | Participants | 1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12) |
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| Secondary | Sexual Function Trial - Sexual Desire Domain | 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. | Posted | Mean | Standard Deviation | Score on the DISF-M-II scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Sexual Function Trial - Erectile Function | 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. | Posted | Mean | Standard Deviation | Score on the IIEF test scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters | Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12 | Posted | Mean | Standard Deviation | meters | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%) | 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. | The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete. | Posted | Count of Participants | Participants | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Physical Function Trial - PF 10 Overall Score | 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. | Posted | Mean | Standard Deviation | Score on the PF-10 test scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Vitality Trial - FACIT Fatigue Overall Score | 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. | Posted | Mean | Standard Deviation | Score on the FACIT- Fatigue test scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Vitality Trial - SF-36 Score | 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. | Posted | Mean | Standard Deviation | Score on the SF-36 vitality scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 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. | Posted | Mean | Standard Deviation | Score on the PANAS test scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 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. | Posted | Mean | Standard Deviation | Score on the PANAS test scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score | 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. | Posted | Mean | Standard Deviation | Score on the PHQ-9 test scale | 1 year (change from baseline to month 3, 6, 9 and 12) |
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| Secondary | Cardiovascular Trial - Total Plaque Volume Change From Baseline | Total plaque volume,mm3 measured by coronary computed tomographic angiography | Posted | Mean | 95% Confidence Interval | mm^3 | 1 year (change from baseline to month 12) |
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| Secondary | Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline | Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis). | All participants with measurements of both baseline and 12-month assessments were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Agatston units | 1 year (change from baseline to month 12) |
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| Secondary | Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT) | Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT) | Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT) | Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT) | Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT) | Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N | Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N | Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N | Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N | Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N | Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N | Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA) | Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA) | Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA) | Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors) | Posted | Mean | 95% Confidence Interval | percentage of change | 1 year (baseline to month 12) |
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| Secondary | Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT) | 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. | Posted | Mean | 95% Confidence Interval | Score on the BVRT test scale | 1 year (baseline to month 6 and month 12) |
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| Secondary | Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT) | 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. | Posted | Mean | 95% Confidence Interval | Score on the CRT test scale | 1 year (baseline to month 6 to month 12) |
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| Secondary | Cognitive Function Trial - Executive Function - Trail Making Test B - A | 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. | Posted | Mean | 95% Confidence Interval | Score on the Trail Making Test scale | 1 year (baseline to month 6 to month 12) |
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| Secondary | Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous) | 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. | Posted | Mean | Standard Deviation | proportion of participants | 1 year (baseline to month 12) |
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| 183 |
| 394 |
| 343 |
| 394 |
| EG001 | 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. | 176 | 394 | 341 | 394 |
| Cardiac disorders | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Respiratory disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| General disorders | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Injury poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Investigations | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Unknown or Not Reported |
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| Other |
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| Change at Month 6 |
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| Change at Month 9 |
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| Change at Month 12 |
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| Change at Month 6 |
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| Change at Month 9 |
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| Change at Month 12 |
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| Change at Month 12 |
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| Change at Month 12 |
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| Change at Month 12 |
|