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| ID | Type | Description | Link |
|---|---|---|---|
| U01AG014369 | U.S. NIH Grant/Contract | View source |
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Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.
The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID).
Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical testosterone gel 1% (active formulation) | Drug | Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Physical Performance Measured by an Exercise Testing Regimen | Primary outcome was a change from baseline in leg-press strength at 6 months. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chest-Press | Change from baseline in chest press strength at 6 months | baseline and 6 months |
| Stair-climbing Test (Without a Load) | Change from baseline in the stair-climbing test (without a load) at 6 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year
Alcohol or drug abuse
Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)
Prostate cancer, breast cancer or other cancers with life expectancy < 5 years
Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems
Any neurological condition that would impact cognitive functioning including:
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months
Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21
Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
Abnormal laboratory values (at discretion of principal investigator)
Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg
Body mass index > 40 kg/m2
Untreated severe obstructive sleep apnea
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| Name | Affiliation | Role |
|---|---|---|
| Shalender Bhasin, MD | Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition | Principal Investigator |
| Shehzad Basaria, MD | Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition | Study Director |
| Wildon Farwell, MD, MPH | VA Boston Healthcare System (Jamaica Plain Campus) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States | ||
| VA Boston Healthcare System (Jamaica Plain Campus) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12145025 | Background | Hughes VA, Frontera WR, Roubenoff R, Evans WJ, Singh MA. Longitudinal changes in body composition in older men and women: role of body weight change and physical activity. Am J Clin Nutr. 2002 Aug;76(2):473-81. doi: 10.1093/ajcn/76.2.473. | |
| 11320101 | Background | Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17. doi: 10.1093/gerona/56.5.b209. |
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The participants were community-dwelling men, aged 65 years and older, with total testosterone between 100 and 350 ng/dL or free testosterone less than 50 pg/mL, and mobility limitation.
All participants provided written, informed consent. Recruitment took place at VAHCS, NERI, and BUMC. Outcome assessments were performed at BUMC. The study consisted of a 24- week intervention followed by a 12-week observation period. Enrollment took place between September 2005 and December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter or a free serum testosterone level of less than 50 pg per milliliter were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes in Physical Performance Measured by an Exercise Testing Regimen | Primary outcome was a change from baseline in leg-press strength at 6 months. | Participants with baseline and at least one post baseline measure. | Posted | Mean | 95% Confidence Interval | Newtons | baseline and 6 months |
|
Adverse event data were collected throughout the entire study period (4 years and 3 months)
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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 | Treatment | Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalender Bhasin | Brigham & Women's Hospital | 617-525-9150 | sbhasin@partners.org |
Not provided
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D007006 | Hypogonadism |
| D009135 | Muscular Diseases |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| D005782 | Gels |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Topical gel (placebo formulation) | Drug | Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day. |
|
| baseline and 6 month |
| Grip Strength | Change from baseline in grip strength in the dominant hand. | baseline and 6 months |
| 50-Meter Walking Speed (Without a Load) | Change from baseline 50-Meter Walking Speed (without a load) at 6 months | baseline and 6 months |
| Stair-climbing Test (Loaded) | Change from baseline in Stair-climbing Test (loaded) | baseline and 6 months |
| Late Life Functional Disability Index (LLFDI) | Percent change from baseline in the late life functional disability index at 6 months | baseline and 6 months |
| Total Lean Mass | baseline, 3 months, and 6 months |
| Total Fat Mass | baseline, 3 months, and 6 months |
| 50-Meter Walking Speed (With a Load) | Change from baseline 50-Meter Walking Speed (with a load) at 6 months | baseline and 6 months |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| 11158037 | Background | Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219. |
| 1829756 | Background | Gray A, Berlin JA, McKinlay JB, Longcope C. An examination of research design effects on the association of testosterone and male aging: results of a meta-analysis. J Clin Epidemiol. 1991;44(7):671-84. doi: 10.1016/0895-4356(91)90028-8. |
| 20592293 | Result | Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30. |
| 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. |
| 29846604 | Derived | Traustadottir T, Harman SM, Tsitouras P, Pencina KM, Li Z, Travison TG, Eder R, Miciek R, McKinnon J, Woodbury E, Basaria S, Bhasin S, Storer TW. Long-Term Testosterone Supplementation in Older Men Attenuates Age-Related Decline in Aerobic Capacity. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2861-2869. doi: 10.1210/jc.2017-01902. |
| 28981994 | Derived | Bhasin S, Travison TG, O'Brien L, MacKrell J, Krishnan V, Ouyang H, Pencina K, Basaria S. Contributors to the substantial variation in on-treatment testosterone levels in men receiving transdermal testosterone gels in randomized trials. Andrology. 2018 Jan;6(1):151-157. doi: 10.1111/andr.12428. Epub 2017 Oct 5. |
| 28950424 | Derived | Gagliano-Juca T, Storer TW, Pencina KM, Travison TG, Li Z, Huang G, Hettwer S, Dahinden P, Bhasin S, Basaria S. Testosterone does not affect agrin cleavage in mobility-limited older men despite improvement in physical function. Andrology. 2018 Jan;6(1):29-36. doi: 10.1111/andr.12424. Epub 2017 Sep 26. |
| 23292288 | Derived | Huang G, Bhasin S, Tang ER, Aakil A, Anderson SW, Jara H, Davda M, Travison TG, Basaria S. Effect of testosterone administration on liver fat in older men with mobility limitation: results from a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Aug;68(8):954-9. doi: 10.1093/gerona/gls259. Epub 2013 Jan 4. |
| 21697501 | Derived | Travison TG, Basaria S, Storer TW, Jette AM, Miciek R, Farwell WR, Choong K, Lakshman K, Mazer NA, Coviello AD, Knapp PE, Ulloor J, Zhang A, Brooks B, Nguyen AH, Eder R, LeBrasseur N, Elmi A, Appleman E, Hede-Brierley L, Bhasin G, Bhatia A, Lazzari A, Davis S, Ni P, Collins L, Bhasin S. Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. J Gerontol A Biol Sci Med Sci. 2011 Oct;66(10):1090-9. doi: 10.1093/gerona/glr100. Epub 2011 Jun 22. |
| 18996225 | Derived | LeBrasseur NK, Lajevardi N, Miciek R, Mazer N, Storer TW, Bhasin S. Effects of testosterone therapy on muscle performance and physical function in older men with mobility limitations (The TOM Trial): design and methods. Contemp Clin Trials. 2009 Mar;30(2):133-40. doi: 10.1016/j.cct.2008.10.005. Epub 2008 Oct 29. |
| Placebo |
Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
|
|
|
| Secondary | Chest-Press | Change from baseline in chest press strength at 6 months | Participants with baseline and 1 post baseline measure. | Posted | Mean | 95% Confidence Interval | Newtons | baseline and 6 months |
|
|
|
|
| Secondary | Stair-climbing Test (Without a Load) | Change from baseline in the stair-climbing test (without a load) at 6 months. | Participants with baseline and one post baseline measure. | Posted | Mean | 95% Confidence Interval | Watts | baseline and 6 month |
|
|
|
|
| Secondary | Grip Strength | Change from baseline in grip strength in the dominant hand. | The participants with baseline and one post baseline measure are included. | Posted | Mean | 95% Confidence Interval | Kilograms | baseline and 6 months |
|
|
|
|
| Secondary | 50-Meter Walking Speed (Without a Load) | Change from baseline 50-Meter Walking Speed (without a load) at 6 months | Participants with a baseline and one post baseline measure. | Posted | Mean | 95% Confidence Interval | meters/second | baseline and 6 months |
|
|
|
|
| Secondary | Stair-climbing Test (Loaded) | Change from baseline in Stair-climbing Test (loaded) | Participants with one baseline and one post baseline measure. | Posted | Mean | 95% Confidence Interval | Watts | baseline and 6 months |
|
|
|
|
| Secondary | Late Life Functional Disability Index (LLFDI) | Percent change from baseline in the late life functional disability index at 6 months | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Total Lean Mass | Posted | Mean | Standard Deviation | Kilograms | baseline, 3 months, and 6 months |
|
|
|
|
| Secondary | Total Fat Mass | Posted | Mean | Standard Deviation | Kilograms | baseline, 3 months, and 6 months |
|
|
|
|
| Secondary | 50-Meter Walking Speed (With a Load) | Change from baseline 50-Meter Walking Speed (with a load) at 6 months | Participants with a baseline and one post baseline measure. | Posted | Mean | 95% Confidence Interval | meters/second | baseline and 6 months |
|
|
|
|
| 16 |
| 106 |
| 35 |
| 106 |
| EG001 | Placebo | Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day. | 8 | 103 | 10 | 103 |
| Diabetic foot ulcer | Metabolism and nutrition disorders |
|
| Prostate cancer | Investigations |
|
| Cholecystitis | Infections and infestations |
|
| Myocardial infarction treated with angioplasty, pacemaker placement | Cardiac disorders |
|
| Myocardial infarction | Cardiac disorders |
|
| Panic attack | Cardiac disorders |
|
| Appendicitis | Infections and infestations |
|
| Angioplasty and coronary artery bypass grafting | Surgical and medical procedures |
|
| Congestive heart failure | Cardiac disorders |
|
| Fracture of the tibia | Injury, poisoning and procedural complications |
|
| Stroke | Nervous system disorders |
|
| Death, suspected myocardial infarction | Cardiac disorders |
|
| Bupropion toxicity | Nervous system disorders |
|
| Peripheral angioplasty and stenting | Surgical and medical procedures |
|
| Clozapine toxicity | Injury, poisoning and procedural complications |
|
| Congestive heart failure exacerbation | Cardiac disorders |
|
| Community acquired pneumonia | Infections and infestations |
|
| Syncope resulting in hospitalization | Nervous system disorders |
|
| Painful neuropathy | Nervous system disorders |
|
| Hepatocellular carcinoma | Hepatobiliary disorders |
|
| Intestinal obstruction | Gastrointestinal disorders |
|
| Transurethral resection of prostate | Surgical and medical procedures |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Splenic rupture | Injury, poisoning and procedural complications |
|
| Inflammatory colonic mass related to Crohn's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Rectal bleeding from Crohn's Disease | Gastrointestinal disorders |
|
| Infections and infestations | Infections and infestations |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
Not provided
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D010335 | Pathologic Processes |
| 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 |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| 0.002 |
Adjusted |
| Mean Difference (Net) |
| 34.5 |
| 2-Sided |
| 95 |
| 13.1 |
| 56.2 |
| Superiority or Other |
| 0.37 |
Adjusted. |
| Mean Difference (Net) |
| 8.1 |
| 2-Sided |
| 95 |
| -9.9 |
| 26.2 |
| Superiority or Other |
| 0.71 |
Adjusted. |
| Mean Difference (Net) |
| 0.26 |
| 2-Sided |
| 95 |
| -1.1 |
| 1.7 |
| Superiority or Other |
| 0.27 |
Adjusted |
| Mean Difference (Net) |
| 0.048 |
| 2-Sided |
| 95 |
| -0.037 |
| 0.133 |
| Superiority or Other |
| 0.05 |
Adjusted |
| Mean Difference (Net) |
| 29.7 |
| 2-Sided |
| 95 |
| 0.2 |
| 59.3 |
| Superiority or Other |
| 6 Months (N=77,80) |
|
| <.0001 |
Month 6 Measures |
| Mean Difference (Net) |
| 1.5 |
| 2-Sided |
| 95 |
| 0.4 |
| 2.2 |
| Superiority or Other |
| 6 Months (N=77,80) |
|
| <.0001 |
6 Month Measures |
| Mean Difference (Net) |
| -2.0 |
| 2-Sided |
| 95 |
| -2.8 |
| -1.2 |
| Superiority or Other |
| 0.14 |
Adjusted. |
| Mean Difference (Net) |
| 0.090 |
| 2-Sided |
| 95 |
| -0.030 |
| 0.209 |
| Superiority or Other |