Sarcopenia
Conditions
Keywords
Sarcopenia, Aging muscle, Androgen, Cytokines, Muscle metabolism
Brief 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. 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: 1. Testosterone by injection (100mg testosterone enanthate) administered on study day 1. 2. Testosterone by gel application (10g/day Androgel 1%) administered daily beginning on study day 1 through study day 7. 3. 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). 4. 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.
Interventions
100 mg single IM injection
DRUGTestosterone gel
Testosterone gel 10 mg. administered topically daily for seven days
DRUGMedrol
Medrol 6 day dose pack with an additional 4mg dose on day 7
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 60-85 * Gender: Male
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
46 subjects screened, 15 subjects did not qualify, 2 subjects did not choose to participate. 29 subjects began the study and 28 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Injection Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection
Testosterone injection: 100 mg single IM injection | 7 |
| Testosterone Gel Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days
Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days | 7 |
| Testosterone Injection and Medrol 6 Day Dose Pack 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.
Testosterone injection: 100 mg single IM injection
Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 | 7 |
| Medrol 6 Day Dose Pack 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: Medrol 6 day dose pack with an additional 4mg dose on day 7 | 8 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Testosterone Injection and Medrol 6 Day Dose Pack | Testosterone Injection | Testosterone Gel | Medrol 6 Day Dose Pack |
|---|---|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 6 | 73 years STANDARD_DEVIATION 7.5 | 72 years STANDARD_DEVIATION 4 | 73 years STANDARD_DEVIATION 5 | 71 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 7 Participants | 7 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fat Mass as measured by DEXA | 28.59 kilograms STANDARD_DEVIATION 9.99 | 25.33 kilograms STANDARD_DEVIATION 26.12 | 28.74 kilograms STANDARD_DEVIATION 28.64 | 33.32 kilograms STANDARD_DEVIATION 33.82 | 28.40 kilograms STANDARD_DEVIATION 28.01 |
| Lean Body Mass as measured by DEXA | 52.77 kilograms STANDARD_DEVIATION 7.73 | 49.22 kilograms STANDARD_DEVIATION 47.85 | 52.60 kilograms STANDARD_DEVIATION 51.42 | 53.06 kilograms STANDARD_DEVIATION 52.66 | 57.34 kilograms STANDARD_DEVIATION 57.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 6 Participants | 7 Participants | 7 Participants | 7 Participants |
| Region of Enrollment United States | 29 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 29 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants |
| Total Mass as Measured by DEXA | 84.42 kilograms STANDARD_DEVIATION 15.8 | 77.51 kilograms STANDARD_DEVIATION 76.93 | 84.2 kilograms STANDARD_DEVIATION 82.83 | 89.6 kilograms STANDARD_DEVIATION 89.7 | 89.04 kilograms STANDARD_DEVIATION 89.15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 8 |
Outcome results
Primary
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.
Time frame: treatment day 1 - after exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol | 7.71 ug/dL | Standard Deviation 3.16 |
| Testosterone Gel | Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol | 7.20 ug/dL | Standard Deviation 2.71 |
| Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol | 4.76 ug/dL | Standard Deviation 1.17 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol | 4.15 ug/dL | Standard Deviation 1.64 |
Primary
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.
Time frame: treatment day 1 - before exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol | 7.25 ug/dL | Standard Deviation 2.16 |
| Testosterone Gel | Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol | 6.00 ug/dL | Standard Deviation 1.67 |
| Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol | 6.64 ug/dL | Standard Deviation 1.71 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol | 6.28 ug/dL | Standard Deviation 1.61 |
Primary
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.
Time frame: treatment day 8 - after exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol | 7.05 ug/dL | Standard Deviation 2.48 |
| Testosterone Gel | Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol | 6.28 ug/dL | Standard Deviation 3.41 |
| Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol | 4.40 ug/dL | Standard Deviation 1.9 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol | 5.78 ug/dL | Standard Deviation 2.38 |
Primary
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.
Time frame: treatment day 8 - before exercise
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol | 7.84 ug/dL | Standard Deviation 3.13 |
| Testosterone Gel | Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol | 5.97 ug/dL | Standard Deviation 2.18 |
| Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol | 6.28 ug/dL | Standard Deviation 2.9 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol | 5.19 ug/dL | Standard Deviation 2.76 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study) | 0.47 mg/dL | Standard Deviation 0.23 |
| Testosterone Gel | C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study) | 0.33 mg/dL | Standard Deviation 0.08 |
| Medrol 6 Day Dose Pack | C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study) | 0.32 mg/dL | Standard Deviation 0.4 |
| Testosterone Injection and Medrol 6 Day Dose Pack | C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study) | 0.4 mg/dL | Standard Deviation 0.22 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study) | 0.47 mg/dL | Standard Deviation 0.22 |
| Testosterone Gel | C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study) | 0.31 mg/dL | Standard Deviation 0.04 |
| Medrol 6 Day Dose Pack | C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study) | 0.32 mg/dL | Standard Deviation 0.4 |
| Testosterone Injection and Medrol 6 Day Dose Pack | C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study) | 0.3 mg/dL | Standard Deviation 0 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study) | 46.34 ug/dL | Standard Deviation 48.14 |
| Testosterone Gel | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study) | 34.16 ug/dL | Standard Deviation 16.54 |
| Medrol 6 Day Dose Pack | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study) | 62.55 ug/dL | Standard Deviation 53.2 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study) | 46.07 ug/dL | Standard Deviation 51.56 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study) | 37.96 ug/dL | Standard Deviation 25.25 |
| Testosterone Gel | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study) | 35.54 ug/dL | Standard Deviation 14.52 |
| Medrol 6 Day Dose Pack | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study) | 34.74 ug/dL | Standard Deviation 30.08 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study) | 36.07 ug/dL | Standard Deviation 35.77 |
Primary
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.
Time frame: Study days 1-7 (treatment week)
Population: 1 subject did not complete the BFI during treatment week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week | 1.84 units on a scale | Standard Deviation 0.3 |
| Testosterone Gel | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week | 1.79 units on a scale | Standard Deviation 0.16 |
| Medrol 6 Day Dose Pack | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week | 2.19 units on a scale | Standard Deviation 0.48 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week | 1.57 units on a scale | Standard Deviation 0.13 |
Primary
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.
Time frame: Study days -7 to -1 (Pre - treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week | 2.25 units on a scale | Standard Deviation 0.41 |
| Testosterone Gel | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week | 1.47 units on a scale | Standard Deviation 0.26 |
| Medrol 6 Day Dose Pack | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week | 2.26 units on a scale | Standard Deviation 0.37 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week | 1.86 units on a scale | Standard Deviation 0.22 |
Primary
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%.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Hematocrit Measured on Treatment Day 1 (Baseline Study) | 39.17 percent | Standard Deviation 2.39 |
| Testosterone Gel | Hematocrit Measured on Treatment Day 1 (Baseline Study) | 38.4 percent | Standard Deviation 3.71 |
| Medrol 6 Day Dose Pack | Hematocrit Measured on Treatment Day 1 (Baseline Study) | 40.45 percent | Standard Deviation 2.92 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Hematocrit Measured on Treatment Day 1 (Baseline Study) | 39.86 percent | Standard Deviation 2.33 |
Primary
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%.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Hematocrit Measured on Treatment Day 8 (Post Study) | 38.74 percent | Standard Deviation 2.15 |
| Testosterone Gel | Hematocrit Measured on Treatment Day 8 (Post Study) | 37.23 percent | Standard Deviation 3.57 |
| Medrol 6 Day Dose Pack | Hematocrit Measured on Treatment Day 8 (Post Study) | 40.53 percent | Standard Deviation 2.47 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Hematocrit Measured on Treatment Day 8 (Post Study) | 39.24 percent | Standard Deviation 2.72 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study) | 40.29 mg/dL | Standard Deviation 6.29 |
| Testosterone Gel | High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study) | 38.86 mg/dL | Standard Deviation 13.47 |
| Medrol 6 Day Dose Pack | High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study) | 46.50 mg/dL | Standard Deviation 8.94 |
| Testosterone Injection and Medrol 6 Day Dose Pack | High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study) | 42.14 mg/dL | Standard Deviation 6.57 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study) | 41.29 mg/dL | Standard Deviation 9.6 |
| Testosterone Gel | High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study) | 36.71 mg/dL | Standard Deviation 8.83 |
| Medrol 6 Day Dose Pack | High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study) | 47.67 mg/dL | Standard Deviation 5.35 |
| Testosterone Injection and Medrol 6 Day Dose Pack | High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study) | 43.43 mg/dL | Standard Deviation 6.24 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study) | 71.77 ng/mL | Standard Deviation 33.99 |
| Testosterone Gel | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study) | 69.2 ng/mL | Standard Deviation 33 |
| Medrol 6 Day Dose Pack | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study) | 61.42 ng/mL | Standard Deviation 40.36 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study) | 90.74 ng/mL | Standard Deviation 65.38 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study) | 80.16 ng/mL | Standard Deviation 39.07 |
| Testosterone Gel | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study) | 72.11 ng/mL | Standard Deviation 26.2 |
| Medrol 6 Day Dose Pack | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study) | 69.17 ng/mL | Standard Deviation 47.64 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study) | 54.86 ng/mL | Standard Deviation 47.34 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Insulin Measured on Treatment Day 1 (Baseline Study) | 8.53 uIu/mL | Standard Deviation 4.11 |
| Testosterone Gel | Insulin Measured on Treatment Day 1 (Baseline Study) | 10.28 uIu/mL | Standard Deviation 8.09 |
| Medrol 6 Day Dose Pack | Insulin Measured on Treatment Day 1 (Baseline Study) | 4.09 uIu/mL | Standard Deviation 2.08 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Insulin Measured on Treatment Day 1 (Baseline Study) | 9.89 uIu/mL | Standard Deviation 10 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Insulin Measured on Treatment Day 8 (Post Study) | 7.47 uIu/mL | Standard Deviation 3.9 |
| Testosterone Gel | Insulin Measured on Treatment Day 8 (Post Study) | 10.58 uIu/mL | Standard Deviation 7.13 |
| Medrol 6 Day Dose Pack | Insulin Measured on Treatment Day 8 (Post Study) | 3.92 uIu/mL | Standard Deviation 1.73 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Insulin Measured on Treatment Day 8 (Post Study) | 3.89 uIu/mL | Standard Deviation 1.8 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study) | 103.0 mg/dL | Standard Deviation 27.76 |
| Testosterone Gel | Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study) | 93.57 mg/dL | Standard Deviation 36.47 |
| Medrol 6 Day Dose Pack | Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study) | 96.83 mg/dL | Standard Deviation 18.24 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study) | 90.71 mg/dL | Standard Deviation 26.57 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study) | 104.0 mg/dL | Standard Deviation 43.64 |
| Testosterone Gel | Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study) | 94.57 mg/dL | Standard Deviation 40.61 |
| Medrol 6 Day Dose Pack | Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study) | 87.5 mg/dL | Standard Deviation 13.91 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study) | 75.14 mg/dL | Standard Deviation 19.79 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study) | 1.92 ng/mL | Standard Deviation 1.13 |
| Testosterone Gel | Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study) | 2.33 ng/mL | Standard Deviation 1.6 |
| Medrol 6 Day Dose Pack | Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study) | 1.85 ng/mL | Standard Deviation 1.02 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study) | 1.83 ng/mL | Standard Deviation 1.25 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study) | 1.98 ng/mL | Standard Deviation 1 |
| Testosterone Gel | Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study) | 2.32 ng/mL | Standard Deviation 1.64 |
| Medrol 6 Day Dose Pack | Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study) | 1.78 ng/mL | Standard Deviation 1.05 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study) | 2.07 ng/mL | Standard Deviation 1.6 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Estradiol Measured on Treatment Day 1 (Baseline Study) | 22.86 pg/mL | Standard Deviation 10.32 |
| Testosterone Gel | Serum Estradiol Measured on Treatment Day 1 (Baseline Study) | 33.69 pg/mL | Standard Deviation 17.04 |
| Medrol 6 Day Dose Pack | Serum Estradiol Measured on Treatment Day 1 (Baseline Study) | 36.33 pg/mL | Standard Deviation 12.12 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Estradiol Measured on Treatment Day 1 (Baseline Study) | 34.71 pg/mL | Standard Deviation 10.95 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Estradiol Measured on Treatment Day 8 (Post Study) | 48.29 pg/mL | Standard Deviation 12.2 |
| Testosterone Gel | Serum Estradiol Measured on Treatment Day 8 (Post Study) | 33.43 pg/mL | Standard Deviation 19.48 |
| Medrol 6 Day Dose Pack | Serum Estradiol Measured on Treatment Day 8 (Post Study) | 30.83 pg/mL | Standard Deviation 7.05 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Estradiol Measured on Treatment Day 8 (Post Study) | 47.14 pg/mL | Standard Deviation 34.87 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | 307.57 ng/dL | Standard Deviation 106.09 |
| Testosterone Gel | Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | 363.43 ng/dL | Standard Deviation 95.76 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | 408.17 ng/dL | Standard Deviation 200.61 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | 318.68 ng/dL | Standard Deviation 129.68 |
Primary
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.
Time frame: treatment day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 2 | 980.86 ng/dL | Standard Deviation 389.58 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 2 | 526.71 ng/dL | Standard Deviation 127.59 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 2 | 191.87 ng/dL | Standard Deviation 90.35 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 2 | 675.86 ng/dL | Standard Deviation 316.83 |
Primary
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.
Time frame: treatment day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 3 | 828.71 ng/dL | Standard Deviation 375.94 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 3 | 527.43 ng/dL | Standard Deviation 183.7 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 3 | 206.0 ng/dL | Standard Deviation 89.35 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 3 | 673.29 ng/dL | Standard Deviation 299.3 |
Primary
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.
Time frame: treatment day 4
Population: One subject missed a testosterone monitoring visit for treatment day 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 4 | 779.57 ng/dL | Standard Deviation 399.73 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 4 | 441.71 ng/dL | Standard Deviation 146.99 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 4 | 271.6 ng/dL | Standard Deviation 134.93 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 4 | 734.57 ng/dL | Standard Deviation 277.34 |
Primary
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.
Time frame: treatment day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 5 | 722.0 ng/dL | Standard Deviation 302.1 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 5 | 460.14 ng/dL | Standard Deviation 211.31 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 5 | 246.33 ng/dL | Standard Deviation 131.3 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 5 | 669.71 ng/dL | Standard Deviation 291.02 |
Primary
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.
Time frame: treatment day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 6 | 629.0 ng/dL | Standard Deviation 272.56 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 6 | 536.43 ng/dL | Standard Deviation 269.53 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 6 | 284.5 ng/dL | Standard Deviation 166 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 6 | 645.14 ng/dL | Standard Deviation 282.11 |
Primary
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.
Time frame: treatment day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 7 | 578.29 ng/dL | Standard Deviation 173.58 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 7 | 485.86 ng/dL | Standard Deviation 211.57 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 7 | 320.0 ng/dL | Standard Deviation 113.06 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 7 | 579.57 ng/dL | Standard Deviation 170.04 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Serum Total Testosterone Measured on Treatment Day 8 (Post Study) | 454.29 ng/dL | Standard Deviation 57.12 |
| Testosterone Gel | Serum Total Testosterone Measured on Treatment Day 8 (Post Study) | 435.14 ng/dL | Standard Deviation 180.11 |
| Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 8 (Post Study) | 340.17 ng/dL | Standard Deviation 127.27 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Serum Total Testosterone Measured on Treatment Day 8 (Post Study) | 481.14 ng/dL | Standard Deviation 141.08 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study) | 21.78 nmol/L | Standard Deviation 11.56 |
| Testosterone Gel | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study) | 19.86 nmol/L | Standard Deviation 8.51 |
| Medrol 6 Day Dose Pack | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study) | 25.66 nmol/L | Standard Deviation 12.85 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study) | 24.70 nmol/L | Standard Deviation 9.63 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study) | 17.62 nmol/L | Standard Deviation 4.8 |
| Testosterone Gel | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study) | 20.13 nmol/L | Standard Deviation 9.72 |
| Medrol 6 Day Dose Pack | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study) | 19.22 nmol/L | Standard Deviation 11.71 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study) | 14.57 nmol/L | Standard Deviation 6.88 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Total Cholesterol Measured on Treatment Day 1 (Baseline Study) | 171.29 mg/dL | Standard Deviation 35.72 |
| Testosterone Gel | Total Cholesterol Measured on Treatment Day 1 (Baseline Study) | 165.57 mg/dL | Standard Deviation 34.89 |
| Medrol 6 Day Dose Pack | Total Cholesterol Measured on Treatment Day 1 (Baseline Study) | 168.00 mg/dL | Standard Deviation 24.51 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Total Cholesterol Measured on Treatment Day 1 (Baseline Study) | 156.71 mg/dL | Standard Deviation 27.32 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Total Cholesterol Measured on Treatment Day 8 (Post Study) | 172 mg/dL | Standard Deviation 46.45 |
| Testosterone Gel | Total Cholesterol Measured on Treatment Day 8 (Post Study) | 162.86 mg/dL | Standard Deviation 37.64 |
| Medrol 6 Day Dose Pack | Total Cholesterol Measured on Treatment Day 8 (Post Study) | 166.17 mg/dL | Standard Deviation 23.57 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Total Cholesterol Measured on Treatment Day 8 (Post Study) | 141.86 mg/dL | Standard Deviation 21.64 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Triglycerides Measured on Treatment Day 1 (Baseline Study) | 140.42 mg/dL | Standard Deviation 50.35 |
| Testosterone Gel | Triglycerides Measured on Treatment Day 1 (Baseline Study) | 164.0 mg/dL | Standard Deviation 44.45 |
| Medrol 6 Day Dose Pack | Triglycerides Measured on Treatment Day 1 (Baseline Study) | 122.5 mg/dL | Standard Deviation 74.89 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Triglycerides Measured on Treatment Day 1 (Baseline Study) | 119.71 mg/dL | Standard Deviation 35.04 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Triglycerides Measured on Treatment Day 8 (Post Study) | 112.57 mg/dL | Standard Deviation 49.9 |
| Testosterone Gel | Triglycerides Measured on Treatment Day 8 (Post Study) | 160.0 mg/dL | Standard Deviation 58.91 |
| Medrol 6 Day Dose Pack | Triglycerides Measured on Treatment Day 8 (Post Study) | 155.17 mg/dL | Standard Deviation 119.23 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Triglycerides Measured on Treatment Day 8 (Post Study) | 116.28 mg/dL | Standard Deviation 22.94 |
Primary
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.
Time frame: treatment day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study) | 28 mg/dL | Standard Deviation 10.13 |
| Testosterone Gel | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study) | 33.14 mg/dL | Standard Deviation 8.51 |
| Medrol 6 Day Dose Pack | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study) | 24.67 mg/dL | Standard Deviation 14.99 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study) | 23.86 mg/dL | Standard Deviation 7.03 |
Primary
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.
Time frame: treatment day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Injection | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study) | 26.71 mg/dL | Standard Deviation 8.5 |
| Testosterone Gel | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study) | 29.29 mg/dL | Standard Deviation 11.07 |
| Medrol 6 Day Dose Pack | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study) | 31.0 mg/dL | Standard Deviation 24.02 |
| Testosterone Injection and Medrol 6 Day Dose Pack | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study) | 24.71 mg/dL | Standard Deviation 6.07 |