AgingEarly Phase 1NCT02679274
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
A Early Phase 1 study testing Testosterone in people with Aging, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2016to 20 Sep 2016
- Phase
- Early Phase 1
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Ages: 60 years or older
- Starting rehabilitative care
Who cannot join
- Inability to perform the functional tests specific to the study protocol
- Diagnosed with carcinomas of the breast or with known or suspected carcinomas of the prostate.
- Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
- Uncontrolled hypertension. Systolic blood pressure =/> 160mm Hg or a diastolic blood pressure =/> 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone, other anabolic steroids and glucocorticoids can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.
- History of significant liver disorders or a 3-fold elevation of liver function tests (Alk phos, ALT, AST). Testosterone can have hepatotoxic effects in some subjects and should be used with careful monitoring of LFTs (liver function), though injections of testosterone at a 100 mg dose is not typically sufficient to negatively affect LFTs.
- History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.
Show all 17Show fewer
- LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels further, though this is not anticipated with testosterone injections of 100 mg/wk.
- Hematocrit greater than 51%.
- Established chronic obstructive pulmonary disease, or untreated sleep apnea.
- Implanted artificial pacemaker/defibrillator. BIA uses small currents and is not recommended for participants with a pacemaker.
- Diagnosed systemic fungal infections.
- Positive screening for HIV or active hepatitis*.
- Use of or history of recent anabolic steroid use (within 3 months).
- Alcohol or drug abuse.
- Any other condition or event considered exclusionary by the PI and covering faculty physician.
- Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women.
- Subjects excluded due to positive screening results, including HIV, HBV or HCV, will be immediately scheduled for counseling and follow-up testing as needed, and will be advised to consult their primary physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gulf Health Care Center
Galveston, Texas, 77555
Gulf Health Care Center
Texas City, Texas, 77590
About this study
Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. The investigators have demonstrated that cycled administration of testosterone improves muscle mass and strength in healthy adults. It is proposed that cycled testosterone administration may be an effective adjuvant therapy for frail older men and women during rehabilitation programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC) rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled study, the investigators will test the effects of cycled testosterone administration (2 week on treatment, 2 weeks off treatment) on body composition and physical function in male and female nursing home residents undergoing rehabilitative care. Primary outcomes will be assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip dynamometers, short physical performance battery (SPPB), and quality of life (QOL) questionnaires. Data from this pilot project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.
Read the detailed description
Frailty with aging is a serious debilitating condition that can further contribute to a downward spiraling of health and physical function. Many long term nursing home patients enter into rehabilitative care programs with the intent to increase strength and physical independence. However, many patients have lasting functional limitations despite rehabilitation programs intended to improve their physical function and sarcopenia and frailty is common among nursing home residents. Aging in general, and frailty in particular, has been associated with decreases in sex hormones, and testosterone treatment has known anabolic effects to muscle of hypogonadal as well has eugonadal males. Effective adjuvant treatments that can be safely employed in conjunction with existing therapies such as rehabilitative care intended to improve function can have profound benefits to the long-term outcome of male and female patients.
The investigators have demonstrated that administration of testosterone (100 mg/wk) starts showing improvements in lean body mass (LBM) as early as 4 weeks and muscle strength by 8 weeks in healthy older community dwelling males (Sheffield-Moore et al., 2011). In this study, both continuous weekly treatment as well as intermittent treatment (4 weeks on testosterone, 4 weeks off testosterone, etc) resulted in similar benefits after 20 weeks. In addition, the investigators recently completed a 10-week study where the investigators showed both the safety and efficacy of cycled testosterone treatment (100 mg/wk for 2 weeks, alternated by 2 weeks of no treatment) in combination with regular exercise in healthy eugonadal adult men confined to continuous bed rest (see preliminary data). In that study, testosterone robustly increased LBM in as little as 2 weeks of bed rest and improvements in LBM were associated with better protection of physical function upon reambulation.
It is proposed that a cycled testosterone paradigm may be a safe and effective adjuvant therapy for frail older nursing home patients undergoing physical rehabilitation. The investigators hypothesize that testosterone treatment in addition to standard-of-care (SOC) physical therapy or rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. The long term goal is to develop effective treatments against the functional declines in muscle mass and strength that contribute to the development and progression of frailty. Therefore, the investigators will test the specific aims outlined below in older male and female residents engaging in rehabilitation care at health care centers in Texas City and Galveston. Men and women (age 60-up) will be recruited as they enroll into rehabilitative care programs, screened upon informed consent, and if eligible, block-randomized (double-blinded) to receive either testosterone enanthate (100 mg/wk for males and 25 mg/wk for females) or placebo (saline) treatment for 10 weeks. The treatment will follow a 2-week cycle (2 weeks on-treatment, 2 weeks off, etc). Primary outcomes will be assessed using non-invasive methods at baseline and at completion of the study after 10 weeks. These outcomes will include body composition as determined with bioelectric impedance analysis (BIA), muscle strength and fatigue by handgrip dynamometry, physical function by a short physical performance battery (SPPB), and quality of life (QOL) by a short battery of questionnaires. Blood samples will be collected at screening for safety and will be repeated at completion of the study for secondary outcome measures (hormones, lipid profiles and blood chemistries).
Specific Aim 1. Determine the effects of cycled testosterone treatment on body composition in male and female nursing home residents undergoing rehabilitative care.
Specific Aim 2. Determine the effects of cycled testosterone treatment on physical function in male and female nursing home residents undergoing rehabilitative care.
Data from this pilot/feasibility project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.
- Conditions
- Aging
- Being tested
- Placebo, Testosterone
- Keywords
- Aging, Frailty, Hypogonadism
- Medical subject headings
- Frailty, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Saline
Intermittent intramuscular injections of saline (males and females).
TestosteroneDrug
Also called Testosterone Enanthate
Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9. Receives: Drug: Placebo |
| Testosterone | Experimental | Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9. Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)
Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).
Measured: 0 to 10 Weeks
Secondary outcomes (12)
Change in Handgrip Strength
Measured using a handgrip dynamometer
Measured: 0 to 10 Weeks
Change in Knee Extension Strength (Seated)
Collected using a manual muscle tester (MMT).
Measured: 0 to 10 Weeks
Change in Hip Abduction Strength (Supine)
Collected using a manual muscle tester (MMT).
Measured: 0 to 10 Weeks
Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Measured: baseline
Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Measured: 10 Weeks
Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Measured: baseline
Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.
During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Measured: 10 Weeks
Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Measured: baseline
Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Measured: 10 Weeks
Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).
During the gait speed section of the Short Physical Performance Battery (SPPB) subjects are timed while walking a predefined 4 meter course. Data is shown as change in speed (meters/second) from baseline (0 weeks) to 10 weeks. A increase in speed indicates a better outcome.
Measured: 0 to 10 Weeks
Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline
During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their faster time.
Measured: baseline
Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their best time.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start16 Feb 2016
- Primary completion20 Sep 2016
- Study completion20 Sep 2016
Why it stopped: Lack of funding.
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.
- Other trials for AgingStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edgar L Dillon, PhD, Principal investigator, University of Texas Medical Branch (UTMB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679274
- Sponsor's protocol ID
- 15-0176
- Status last verified
- Jan 2019
- First submitted
- 15 Dec 2015
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
- ClinicalTrials.gov ID
- NCT02679274
- Acronym / sponsor ID
- 15-0176
- Conditions
- Aging
- Keywords
- Aging, Frailty, Hypogonadism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. The investigators have demonstrated that cycled administration of testosterone improves muscle mass and strength in healthy adults. It is proposed that cycled testosterone administration may be an effective adjuvant therapy for frail older men and women during rehabilitation programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC) rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled study, the investigators will test the effects of cycled testosterone administration (2 week on treatment, 2 weeks off treatment) on body composition and physical function in male and female nursing home residents undergoing rehabilitative care. Primary outcomes will be assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip dynamometers, short physical performance battery (SPPB), and quality of life (QOL) questionnaires. Data from this pilot project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.
Detailed description
Frailty with aging is a serious debilitating condition that can further contribute to a downward spiraling of health and physical function. Many long term nursing home patients enter into rehabilitative care programs with the intent to increase strength and physical independence. However, many patients have lasting functional limitations despite rehabilitation programs intended to improve their physical function and sarcopenia and frailty is common among nursing home residents. Aging in general, and frailty in particular, has been associated with decreases in sex hormones, and testosterone treatment has known anabolic effects to muscle of hypogonadal as well has eugonadal males. Effective adjuvant treatments that can be safely employed in conjunction with existing therapies such as rehabilitative care intended to improve function can have profound benefits to the long-term outcome of male and female patients.
The investigators have demonstrated that administration of testosterone (100 mg/wk) starts showing improvements in lean body mass (LBM) as early as 4 weeks and muscle strength by 8 weeks in healthy older community dwelling males (Sheffield-Moore et al., 2011). In this study, both continuous weekly treatment as well as intermittent treatment (4 weeks on testosterone, 4 weeks off testosterone, etc) resulted in similar benefits after 20 weeks. In addition, the investigators recently completed a 10-week study where the investigators showed both the safety and efficacy of cycled testosterone treatment (100 mg/wk for 2 weeks, alternated by 2 weeks of no treatment) in combination with regular exercise in healthy eugonadal adult men confined to continuous bed rest (see preliminary data). In that study, testosterone robustly increased LBM in as little as 2 weeks of bed rest and improvements in LBM were associated with better protection of physical function upon reambulation.
It is proposed that a cycled testosterone paradigm may be a safe and effective adjuvant therapy for frail older nursing home patients undergoing physical rehabilitation. The investigators hypothesize that testosterone treatment in addition to standard-of-care (SOC) physical therapy or rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. The long term goal is to develop effective treatments against the functional declines in muscle mass and strength that contribute to the development and progression of frailty. Therefore, the investigators will test the specific aims outlined below in older male and female residents engaging in rehabilitation care at health care centers in Texas City and Galveston. Men and women (age 60-up) will be recruited as they enroll into rehabilitative care programs, screened upon informed consent, and if eligible, block-randomized (double-blinded) to receive either testosterone enanthate (100 mg/wk for males and 25 mg/wk for females) or placebo (saline) treatment for 10 weeks. The treatment will follow a 2-week cycle (2 weeks on-treatment, 2 weeks off, etc). Primary outcomes will be assessed using non-invasive methods at baseline and at completion of the study after 10 weeks. These outcomes will include body composition as determined with bioelectric impedance analysis (BIA), muscle strength and fatigue by handgrip dynamometry, physical function by a short physical performance battery (SPPB), and quality of life (QOL) by a short battery of questionnaires. Blood samples will be collected at screening for safety and will be repeated at completion of the study for secondary outcome measures (hormones, lipid profiles and blood chemistries).
Specific Aim 1. Determine the effects of cycled testosterone treatment on body composition in male and female nursing home residents undergoing rehabilitative care.
Specific Aim 2. Determine the effects of cycled testosterone treatment on physical function in male and female nursing home residents undergoing rehabilitative care.
Data from this pilot/feasibility project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9. |
| Testosterone | Experimental | Drug: TestosteroneTestosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- Ages: 60 years or older
- Starting rehabilitative care
Key exclusion criteria (17 listed)
- Inability to perform the functional tests specific to the study protocol
- Diagnosed with carcinomas of the breast or with known or suspected carcinomas of the prostate.
- Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
- Uncontrolled hypertension. Systolic blood pressure =/> 160mm Hg or a diastolic blood pressure =/> 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone, other anabolic steroids and glucocorticoids can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.
- History of significant liver disorders or a 3-fold elevation of liver function tests (Alk phos, ALT, AST). Testosterone can have hepatotoxic effects in some subjects and should be used with careful monitoring of LFTs (liver function), though injections of testosterone at a 100 mg dose is not typically sufficient to negatively affect LFTs.
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 |
|---|---|---|
| PlaceboAlso: SalineIntermittent intramuscular injections of saline (males and females). | Drug | Placebo |
| TestosteroneAlso: Testosterone EnanthateIntermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females). | Drug | Testosterone |
Primary outcome
Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)
Time frame: 0 to 10 Weeks
Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).
12 secondary outcomes
Change in Handgrip Strength
Time frame: 0 to 10 Weeks
Change in Knee Extension Strength (Seated)
Time frame: 0 to 10 Weeks
Change in Hip Abduction Strength (Supine)
Time frame: 0 to 10 Weeks
Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
Time frame: baseline
Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
Time frame: 10 Weeks
Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
Time frame: baseline
Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.
Time frame: 10 Weeks
Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
Time frame: baseline
Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
Time frame: 10 Weeks
Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).
Time frame: 0 to 10 Weeks
Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline
Time frame: baseline
Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
Time frame: 10 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Edgar L Dillon, PhD principal investigator
University of Texas Medical Branch (UTMB)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Testosterone in people with Aging, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 17 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 18 Feb 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 18 Feb 2019). 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?
Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA) (time frame: 0 to 10 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2019.