SarcopeniaPhase 4NCT00957801
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
A Phase 4 study testing Testosterone injection, Testosterone gel and Medrol in people with Sarcopenia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process. Read more about this study
- Who is it for?
- Ages 60 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Testosterone injection, Testosterone gel and Medrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2015
- 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 60 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 60-85
- Gender: Male
Who cannot join
- Exclusionary medications will be an anticoagulant (Coumadin) because of the risk of bleeding during the biopsy procedure. Additional medications which will be disallowed for participation include: anabolic steroids, nitrates, antihistamines, and glucocorticoids.
- The subjects must be able to successfully complete an exercise stress test using the Bruce protocol . Subjects will be excluded without exercise testing, with a history of angina that occurs with exertion or at rest, or a myocardial infarction within the last 12 months. Subjects that demonstrate ³0.1 milliVolts (mV) horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ³10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ³10 premature ventricular contractions (PVC)/min, or couplets) during the stress test will be excluded.
- Subjects with LDL cholesterol above 200 mg/dL will be excluded .
- Any man with a history of breast cancer or prostate cancer, or any indication of an occult carcinoma from an elevation of prostate specific antigen (PSA) above 4.0 mg/L (53), or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream) will be excluded.
- Subjects with liver dysfunction evidenced by a history of hepatitis B or hepatitis C, or by a three-fold elevation of liver enzymes (Alk phos, alanine aminotransferase (ALT), aspartate amino-transferase (AST) above normal on screening will be excluded from the study.
- Any subject with a blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ³ 140 or a diastolic blood pressure ³ 90 will be excluded.
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- Any subject who has a major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea will be excluded. Moreover, subjects will not have a recent history of smoking tobacco. Morbidly obese older men (BMI > 35) will also be excluded.
- Subjects will evidence of kidney disease (serum creatinine > 2.0mg/dl) will be excluded from participation.
- Any subject with thyroid disease as determined by an abnormal thyroid stimulating hormone (TSH) level will be excluded from participation.
- Any subject testing positive for HIV will be excluded .
- Allergy to iodine, a component of Betadine which is used to prepare the subject's skin for invasive procedures, will be cause for exclusion from this study.
- Men with serum total testosterone concentrations greater than 500 ng/dL will be excluded.
- Subjects who engage in high intensity resistance training on a regular basis will be excluded.
- Subjects with a known coagulation disorder or with clinical evidence indicative of a bleeding disorder (easy bruising, "free bleeders") will not be enrolled in this study due to potential problems that could arise from muscle biopsy procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0567
About this study
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process.
The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.
Read the detailed description
4 groups of healthy men aged 60 - 85 years were studied over 15 days, in 2 distinct time periods, pre-treatment and treatment.
Pre treatment week from study day -7 to study day -1. Treatment week from study day 1 to study day 8.
Groups:
- Testosterone by injection (100mg testosterone enanthate) administered on study day 1.
- Testosterone by gel application (10g/day Androgel 1%) administered daily beginning on study day 1 through study day 7.
- Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg).
- Testosterone by injection (100mg testosterone enanthate) administered on study day 1 and Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg).
Subjects were asked to fill out the Brief Fatigue Inventory daily for all 15 days.
Subjects were studied at the clinical research center before treatment (study day 1) and after treatment (study day 8). Resistance exercise was performed on study days 1 and 8. Blood was drawn before and after exercise for measurement of serum cortisol. Subjects were asked to return to the clinical research center each day during the treatment week (study days 1-8) for blood draws for measurement of total testosterone, estradiol and C-reactive protein (CRP). Labs were drawn on study days 1 and 8 for complete blood count, comprehensive metabolic panel and lipid panel.
Part 1:
In this part of the project we will study the acute response to testosterone treatment between two groups of subjects, comparing two methods of administration (injection vs. topical gel) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
Part 2:
In this part of the project we will study the acute response to Medrol (methylprednisolone) taken over 7 days with or without testosterone (given as 100mg IM) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
- Conditions
- Sarcopenia
- Being tested
- Testosterone injection, Testosterone gel, Medrol
- Keywords
- Sarcopenia, Aging muscle, Androgen, Cytokines, Muscle metabolism
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone injectionDrug
Also called Testosterone enanthate
100 mg single IM injection
Testosterone gelDrug
Also called Androgel 1%
Testosterone gel 10 mg. administered topically daily for seven days
MedrolDrug
Also called methylprednisolone, Medrol dose pack
Medrol 6 day dose pack with an additional 4mg dose on day 7
| Study group | Role | What they receive |
|---|---|---|
| Testosterone injection | Active comparator | Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Receives: Drug: Testosterone injection |
| Testosterone gel | Active comparator | Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days Receives: Drug: Testosterone gel |
| Testosterone injection and Medrol 6 day dose pack | Active comparator | Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Receives: Drug: Testosterone injection; Drug: Medrol |
| Medrol 6 day dose pack | Active comparator | Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Receives: Drug: Medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 1
Serum Total Testosterone Measured on Treatment Day 2
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 2
Serum Total Testosterone Measured on Treatment Day 3
TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 3
Serum Total Testosterone Measured on Treatment Day 4
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 4
Serum Total Testosterone Measured on Treatment Day 5
TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 5
Serum Total Testosterone Measured on Treatment Day 6
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 6
Serum Total Testosterone Measured on Treatment Day 7
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 7
Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.
Baseline testosterone was drawn before testosterone administration.
Measured: treatment day 8
Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.
Measured: treatment day 1
Serum Estradiol Measured on Treatment Day 8 (Post Study)
Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.
Measured: treatment day 8
Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.
Measured: treatment day 1
Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.
Measured: treatment day 8
Hematocrit Measured on Treatment Day 1 (Baseline Study)
Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.
Measured: treatment day 1
Hematocrit Measured on Treatment Day 8 (Post Study)
Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.
Measured: treatment day 8
Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.
Measured: treatment day 1
Total Cholesterol Measured on Treatment Day 8 (Post Study)
Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.
Measured: treatment day 8
Triglycerides Measured on Treatment Day 1 (Baseline Study)
Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.
Measured: treatment day 1
Triglycerides Measured on Treatment Day 8 (Post Study)
Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.
Measured: treatment day 8
High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.
Measured: treatment day 1
High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.
Measured: treatment day 8
Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.
Measured: treatment day 1
Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.
Measured: treatment day 8
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.
Measured: treatment day 1
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.
Measured: treatment day 8
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.
Measured: treatment day 1
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.
Measured: treatment day 8
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.
Measured: treatment day 1
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.
Measured: treatment day 8
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.
Measured: treatment day 1
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.
Measured: treatment day 8
Insulin Measured on Treatment Day 1 (Baseline Study)
Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.
Measured: treatment day 1
Insulin Measured on Treatment Day 8 (Post Study)
Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.
Measured: treatment day 8
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.
Measured: treatment day 1
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.
Measured: treatment day 8
Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Measured: treatment day 1 - before exercise
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Measured: treatment day 1 - after exercise
Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Measured: treatment day 8 - before exercise
Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Measured: treatment day 8 - after exercise
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.
This data is presented as the pre-treatment week average of study days -7 to -1.
Measured: Study days -7 to -1 (Pre - treatment)
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.
This data is presented as the treatment week average of study days 1-8.
Measured: Study days 1-7 (treatment week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2015
- Study completionDec 2015
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 SarcopeniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Urban, M.D., Principal investigator, The University of Texas Medical Branch at Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957801
- Sponsor's protocol ID
- 09-070
- Status last verified
- Apr 2018
- First submitted
- 10 Aug 2009
- Last updated
- 8 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
- ClinicalTrials.gov ID
- NCT00957801
- Acronym / sponsor ID
- 09-070
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Aging muscle, Androgen, Cytokines, Muscle metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 4 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process.
The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.
Detailed description
4 groups of healthy men aged 60 - 85 years were studied over 15 days, in 2 distinct time periods, pre-treatment and treatment.
Pre treatment week from study day -7 to study day -1. Treatment week from study day 1 to study day 8.
Groups:
- Testosterone by injection (100mg testosterone enanthate) administered on study day 1.
- Testosterone by gel application (10g/day Androgel 1%) administered daily beginning on study day 1 through study day 7.
- Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg).
- Testosterone by injection (100mg testosterone enanthate) administered on study day 1 and Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg).
Subjects were asked to fill out the Brief Fatigue Inventory daily for all 15 days.
Subjects were studied at the clinical research center before treatment (study day 1) and after treatment (study day 8). Resistance exercise was performed on study days 1 and 8. Blood was drawn before and after exercise for measurement of serum cortisol. Subjects were asked to return to the clinical research center each day during the treatment week (study days 1-8) for blood draws for measurement of total testosterone, estradiol and C-reactive protein (CRP). Labs were drawn on study days 1 and 8 for complete blood count, comprehensive metabolic panel and lipid panel.
Part 1:
In this part of the project we will study the acute response to testosterone treatment between two groups of subjects, comparing two methods of administration (injection vs. topical gel) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
Part 2:
In this part of the project we will study the acute response to Medrol (methylprednisolone) taken over 7 days with or without testosterone (given as 100mg IM) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Testosterone injection | Active comparator | Drug: Testosterone injectionTestosterone enanthate given as a single 100 mg Intramuscular (IM) injection |
| Testosterone gel | Active comparator | Drug: Testosterone gelTestosterone topical gel (Androgel 1%) 10 mg administered daily for seven days |
| Testosterone injection and Medrol 6 day dose pack | Active comparator | Drug: Testosterone injection, Drug: MedrolTestosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. |
| Medrol 6 day dose pack | Active comparator | Drug: MedrolMedrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 60-85
- Gender: Male
Key exclusion criteria (14 listed)
- Exclusionary medications will be an anticoagulant (Coumadin) because of the risk of bleeding during the biopsy procedure. Additional medications which will be disallowed for participation include: anabolic steroids, nitrates, antihistamines, and glucocorticoids.
- The subjects must be able to successfully complete an exercise stress test using the Bruce protocol . Subjects will be excluded without exercise testing, with a history of angina that occurs with exertion or at rest, or a myocardial infarction within the last 12 months. Subjects that demonstrate ³0.1 milliVolts (mV) horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ³10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ³10 premature ventricular contractions (PVC)/min, or couplets) during the stress test will be excluded.
- Subjects with LDL cholesterol above 200 mg/dL will be excluded .
- Any man with a history of breast cancer or prostate cancer, or any indication of an occult carcinoma from an elevation of prostate specific antigen (PSA) above 4.0 mg/L (53), or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream) will be excluded.
- Subjects with liver dysfunction evidenced by a history of hepatitis B or hepatitis C, or by a three-fold elevation of liver enzymes (Alk phos, alanine aminotransferase (ALT), aspartate amino-transferase (AST) above normal on screening will be excluded from the study.
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 |
|---|---|---|
| Testosterone injectionAlso: Testosterone enanthate100 mg single IM injection | Drug | Testosterone injection, Testosterone injection and Medrol 6 day dose pack |
| Testosterone gelAlso: Androgel 1%Testosterone gel 10 mg. administered topically daily for seven days | Drug | Testosterone gel |
| MedrolAlso: methylprednisolone, Medrol dose packMedrol 6 day dose pack with an additional 4mg dose on day 7 | Drug | Medrol 6 day dose pack, Testosterone injection and Medrol 6 day dose pack |
Primary outcome
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 2
Time frame: treatment day 2
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 3
Time frame: treatment day 3
TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 4
Time frame: treatment day 4
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 5
Time frame: treatment day 5
TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 6
Time frame: treatment day 6
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 7
Time frame: treatment day 7
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.
Serum Estradiol Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.
Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.
Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.
Hematocrit Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.
Hematocrit Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.
Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.
Total Cholesterol Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.
Triglycerides Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.
Triglycerides Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.
High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.
High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.
Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.
Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.
Insulin Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.
Insulin Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
Time frame: treatment day 1
Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
Time frame: treatment day 8
Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.
Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
Time frame: treatment day 1 - before exercise
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
Time frame: treatment day 1 - after exercise
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
Time frame: treatment day 8 - before exercise
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
Time frame: treatment day 8 - after exercise
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
Time frame: Study days -7 to -1 (Pre - treatment)
The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the pre-treatment week average of study days -7 to -1.
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
Time frame: Study days 1-7 (treatment week)
The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the treatment week average of study days 1-8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Randall J Urban, M.D. principal investigator
The University of Texas Medical Branch at Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone injection, Testosterone gel and Medrol in people with Sarcopenia, run by The University of Texas Medical Branch, Galveston at 1 site 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 2 inclusion and 14 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: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 Apr 2018). 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?
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) (time frame: treatment day 1). The study lists 40 primary outcomes in all. 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 8 May 2018.