SarcopeniaPhase 4NCT00240981
TOM: Testosterone in Older Men With Sarcopenia
A Phase 4 study testing Topical testosterone gel 1% (active formulation) in people with Sarcopenia and Hypogonadism, run by Boston Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Sarcopenia, Hypogonadism, Muscular Diseases
- What is being tested?
- Topical testosterone gel 1% (active formulation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Community dwelling, ages 65 and older
- Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
- A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
- Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL
- Without dementia (Mini-Mental State Examination [MMSE] score > 24)
Who cannot join
- 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:
Show all 19Show fewer
- epilepsy
- multiple sclerosis
- HIV
- Parkinson's disease
- stroke
- other focal lesion
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University Medical Center
Boston, Massachusetts, 02118
VA Boston Healthcare System (Jamaica Plain Campus)
Boston, Massachusetts, 02130
About this study
Official title: Testosterone Replacement for Older Men With Sarcopenia
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.
Read the detailed description
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.
- Conditions
- Sarcopenia, Hypogonadism, Muscular Diseases
- Being tested
- Topical testosterone gel 1% (active formulation), Topical gel (placebo formulation)
- Keywords
- Andropause, frailty, hormone replacement therapy, Aging
- Medical subject headings
- Sarcopenia, Hypogonadism, Muscular Diseases, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical testosterone gel 1% (active formulation)Drug
Also called Testim®
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.
Topical gel (placebo formulation)Drug
Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Topical testosterone gel 1% (active formulation) |
| Placebo | Placebo comparator | Not described Receives: Drug: Topical gel (placebo formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Physical Performance Measured by an Exercise Testing Regimen
Primary outcome was a change from baseline in leg-press strength at 6 months.
Measured: baseline and 6 months
Secondary outcomes (9)
Chest-Press
Change from baseline in chest press strength at 6 months
Measured: baseline and 6 months
Stair-climbing Test (Without a Load)
Change from baseline in the stair-climbing test (without a load) at 6 months.
Measured: baseline and 6 month
Grip Strength
Change from baseline in grip strength in the dominant hand.
Measured: baseline and 6 months
50-Meter Walking Speed (Without a Load)
Change from baseline 50-Meter Walking Speed (without a load) at 6 months
Measured: baseline and 6 months
Stair-climbing Test (Loaded)
Change from baseline in Stair-climbing Test (loaded)
Measured: baseline and 6 months
Late Life Functional Disability Index (LLFDI)
Percent change from baseline in the late life functional disability index at 6 months
Measured: baseline and 6 months
Total Lean Mass
Measured: baseline, 3 months, and 6 months
Total Fat Mass
Measured: 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
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shalender Bhasin, Boston Medical Center
- Investigators
- Shalender Bhasin, MD, Principal investigator, Boston University Medical Center, Section of Endocrinology, Diabetes, and NutritionShehzad Basaria, MD, Study director, Boston University Medical Center, Section of Endocrinology, Diabetes, and NutritionWildon Farwell, MD, MPH, Principal investigator, VA Boston Healthcare System (Jamaica Plain Campus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240981
- Sponsor's protocol ID
- AG0057
- Other IDs
- U01AG014369
- Status last verified
- Feb 2017
- First submitted
- 14 Oct 2005
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 12145025Hughes 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.
PubMed 11320101Harman 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.
PubMed 11158037Gray 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.
PubMed 1829756Basaria 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.
PubMed 20592293Lee 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.
PubMed 38224135Traustadottir 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.
PubMed 29846604Bhasin 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.
PubMed 28981994Gagliano-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.
PubMed 28950424Huang 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.
PubMed 23292288Travison 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.
PubMed 21697501LeBrasseur 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.
PubMed 18996225
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Replacement for Older Men With Sarcopenia
- ClinicalTrials.gov ID
- NCT00240981
- Acronym / sponsor ID
- AG0057
- Conditions
- Sarcopenia, Hypogonadism, Muscular Diseases
- Keywords
- Andropause, frailty, hormone replacement therapy, Aging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Higher incidence of cardiovascular events in the testosterone arm of the trial. Decision taken by the DSMB on December 31st, 2009.
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Topical testosterone gel 1% (active formulation) |
| Placebo | Placebo comparator | Drug: Topical gel (placebo formulation) |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Community dwelling, ages 65 and older
- Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
- A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
- Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL
- Without dementia (Mini-Mental State Examination [MMSE] score > 24)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical testosterone gel 1% (active formulation)Also: Testim®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. | Drug | Treatment |
| Topical gel (placebo formulation)Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day. | Drug | Placebo |
Primary outcome
Changes in Physical Performance Measured by an Exercise Testing Regimen
Time frame: baseline and 6 months
Primary outcome was a change from baseline in leg-press strength at 6 months.
9 secondary outcomes
Chest-Press
Time frame: baseline and 6 months
Stair-climbing Test (Without a Load)
Time frame: baseline and 6 month
Grip Strength
Time frame: baseline and 6 months
50-Meter Walking Speed (Without a Load)
Time frame: baseline and 6 months
Stair-climbing Test (Loaded)
Time frame: baseline and 6 months
Late Life Functional Disability Index (LLFDI)
Time frame: baseline and 6 months
Total Lean Mass
Time frame: baseline, 3 months, and 6 months
Total Fat Mass
Time frame: baseline, 3 months, and 6 months
50-Meter Walking Speed (With a Load)
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12145025Hughes 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.
- Background: PubMed 11320101Hughes 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.
- Background: PubMed 11158037Harman 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.
- Background: PubMed 1829756Gray 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.
- Results publication: PubMed 20592293Basaria 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.
- Derived from this study: PubMed 38224135Lee 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.
- Derived from this study: PubMed 29846604Traustadottir 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.
- Derived from this study: PubMed 28981994Bhasin 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.
- Derived from this study: PubMed 28950424Gagliano-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.
- Derived from this study: PubMed 23292288Huang 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.
- Derived from this study: PubMed 21697501Travison 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.
- Derived from this study: PubMed 18996225LeBrasseur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalender Bhasin, MD principal investigator
Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition
Shehzad Basaria, MD study director
Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition
Wildon Farwell, MD, MPH principal investigator
VA Boston Healthcare System (Jamaica Plain Campus)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical testosterone gel 1% (active formulation) in people with Sarcopenia and Hypogonadism, run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Physical Performance Measured by an Exercise Testing Regimen (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00240981, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.