Hypogonadism
Conditions
Keywords
Low Normal Testosterone, Male, Aging
Brief summary
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.
Detailed description
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older individuals are prone to falls that prevent independent living and diminish the quality of life. There is a need to develop therapies to counteract losses in skeletal muscle strength with aging. Studies show that exercise and testosterone administration increase skeletal muscle mass and strength in older men. However, the increase in muscle strength by testosterone in older men has not been consistent in all studies. Androgens increase muscle mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown. This proposal will investigate the hypothesis that cyclic testosterone administration (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a consistent and greater improvement in muscle strength than continuous testosterone administration.
Interventions
DRUGTestosterone
Weekly im injections of 100 mg testosterone enanthate.
DRUGPlacebo
Weekly IM injections of sesame oil.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
Exclusion criteria
* Medications such as anticoagulants (Coumadin) and glucocorticoids. * History of angina that occurs with exertion or at rest. * History of myocardial infarction within the last 12 months. * Failure to successfully complete an exercise stress test using the Bruce protocol. Subjects that demonstrate ≥ 0.1 mV horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ≥ 10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ≥ 10 PVC/min, or couplets) during the stress test will be excluded. * LDL cholesterol above 200 mg/dL. * History of prostatic cancer. * Elevated prostate specific antigen (PSA) above 4.0 µg/L, or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream). * Serum total testosterone concentrations of greater than 500 ng/dL. * Subjects who engage in high intensity, elite training on a regular basis. * Major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea. * Recent history of smoking tobacco. * Hematocrit greater than 51%. * Morbidly obese older men (BMI \> 35). * Hypertension: Blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ≥ 140 or a diastolic blood pressure ≥ 90. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria. * History of hepatitis or a 3-fold elevation of liver function tests (Alk phos, ALT, AST). * Bone related disorders such as osteoporosis or parathyroid disease. * DEXA scans revealing lumbar spine T-scores of less than -2.5. * Subjects currently taking anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | 5 Months | The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-\[ring-13C6\]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = \[(EP2 - EP1)/(EM•t)\]•60•100, where EP1 and EP2 are the enrichments of bound L-\[ring-13C6\]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-\[ring-13C6\]-phenylalanine enrichment in the muscle intracellular pool. |
| Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | 5 months | Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings). |
| Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | 5 months | Lean body mass is expressed in grams as calculated by Hologic DEXA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | 5 months | Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months |
| Changes in Serum Markers of Bone Turnover. | 5 months | Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include: Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium |
| 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | 5 months | Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months |
Countries
United States
Participant flow
Recruitment details
Subject recruitment began in January, 2006 and was closed on December, 2011. Subjects were enrolled at the University of Texas Medical Branch in the Institute for Translational Sciences Clinical Research Center (ITS-CRC).
Pre-assignment details
Screening was conducted at the ITS-CRC where the subject was consented and screening was conducted to identify eligible subjects.Screening included blood testing and a stress test to determine fitness for physical function testing. Subjects were excluded due to elevated PSA levels, testosterone levels above entry criteria or occult disease.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Weekly placebo treatment for a duration of 5 months. | 8 |
| Monthly Cycled Testosterone A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. | 9 |
| Continuous Testosterone Weekly testosterone treatment for a duration of 5 months | 9 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Monthly Cycled Testosterone | Continuous Testosterone | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 3 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants | 10 Participants |
| Age Continuous | 71.6 years STANDARD_DEVIATION 7.78 | 73.3 years STANDARD_DEVIATION 7.54 | 65.4 years STANDARD_DEVIATION 3.22 | 70.1 years STANDARD_DEVIATION 6.18 |
| Region of Enrollment United States | 9 participants | 9 participants | 8 participants | 26 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 8 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 8 | 0 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months
The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-\[ring-13C6\]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = \[(EP2 - EP1)/(EM•t)\]•60•100, where EP1 and EP2 are the enrichments of bound L-\[ring-13C6\]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-\[ring-13C6\]-phenylalanine enrichment in the muscle intracellular pool.
Time frame: 5 Months
Population: Subjects who completed the entire treatment protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Baseline | 0.05 Percent per hour (%/hr) | Standard Deviation 0.01 |
| Placebo | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Five Months | 0.066 Percent per hour (%/hr) | Standard Deviation 0.02 |
| Monthly Cycled Testosterone | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Baseline | 0.06 Percent per hour (%/hr) | Standard Deviation 0.01 |
| Monthly Cycled Testosterone | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Five Months | 0.094 Percent per hour (%/hr) | Standard Deviation 0.014 |
| Continuous Testosterone | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Baseline | 0.06 Percent per hour (%/hr) | Standard Deviation 0.01 |
| Continuous Testosterone | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Five Months | 0.101 Percent per hour (%/hr) | Standard Deviation 0.043 |
Primary
Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Lean body mass is expressed in grams as calculated by Hologic DEXA.
Time frame: 5 months
Population: All subjects who successfully completed the five month protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Baseline | 62344 grams | Standard Deviation 10368 |
| Placebo | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 1 | 62994.7 grams | Standard Deviation 10308.8 |
| Placebo | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 2 | 62038.7 grams | Standard Deviation 10556.5 |
| Placebo | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 3 | 62256.5 grams | Standard Deviation 9881.65 |
| Placebo | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 4 | 62755.4 grams | Standard Deviation 10756.2 |
| Placebo | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Month 5 | 61250.6 grams | Standard Deviation 11283.3 |
| Monthly Cycled Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Month 5 | 58846.9 grams | Standard Deviation 6995.48 |
| Monthly Cycled Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Baseline | 57101 grams | Standard Deviation 6671.5 |
| Monthly Cycled Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 3 | 59186 grams | Standard Deviation 6267.63 |
| Monthly Cycled Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 4 | 59838.6 grams | Standard Deviation 7010.73 |
| Monthly Cycled Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 1 | 59155.4 grams | Standard Deviation 6890.9 |
| Monthly Cycled Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 2 | 56787.8 grams | Standard Deviation 6444.16 |
| Continuous Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 1 | 60469.3 grams | Standard Deviation 6555.92 |
| Continuous Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 2 | 62680.1 grams | Standard Deviation 4034.41 |
| Continuous Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Month 5 | 60871.4 grams | Standard Deviation 6840.45 |
| Continuous Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 3 | 61167.3 grams | Standard Deviation 7530.43 |
| Continuous Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Baseline | 57746 grams | Standard Deviation 6485.1 |
| Continuous Testosterone | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lean Body Mass Month 4 | 61436.6 grams | Standard Deviation 6997.17 |
Primary
Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months
Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 3 | 39 pounds | Standard Deviation 9 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Baseline | 40 pounds | Standard Deviation 9 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Baseline | 46 pounds | Standard Deviation 6 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Baseline | 70 pounds | Standard Deviation 21 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 1 | 39 pounds | Standard Deviation 10 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 2 | 38 pounds | Standard Deviation 9 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Baseline | 39 pounds | Standard Deviation 12 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 4 | 38 pounds | Standard Deviation 10 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 5 | 40 pounds | Standard Deviation 11 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 1 | 40 pounds | Standard Deviation 7 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 2 | 41 pounds | Standard Deviation 8 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 3 | 42 pounds | Standard Deviation 8 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 4 | 42 pounds | Standard Deviation 8 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 5 | 42 pounds | Standard Deviation 8 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 1 | 48 pounds | Standard Deviation 7 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 2 | 51 pounds | Standard Deviation 11 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 3 | 48 pounds | Standard Deviation 7 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 4 | 48 pounds | Standard Deviation 7 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 5 | 48 pounds | Standard Deviation 10 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 1 | 70 pounds | Standard Deviation 13 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 2 | 69 pounds | Standard Deviation 14 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 3 | 74 pounds | Standard Deviation 13 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extensuion Month 4 | 72 pounds | Standard Deviation 14 |
| Placebo | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 5 | 72 pounds | Standard Deviation 14 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 3 | 80 pounds | Standard Deviation 14 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Baseline | 39 pounds | Standard Deviation 10 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 4 | 44 pounds | Standard Deviation 8 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 3 | 43 pounds | Standard Deviation 20 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Baseline | 41 pounds | Standard Deviation 14 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 2 | 42 pounds | Standard Deviation 9 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 2 | 77 pounds | Standard Deviation 16 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Baseline | 44 pounds | Standard Deviation 7 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 5 | 45 pounds | Standard Deviation 8 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extensuion Month 4 | 79 pounds | Standard Deviation 16 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Baseline | 73 pounds | Standard Deviation 15 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 1 | 41 pounds | Standard Deviation 10 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 4 | 50 pounds | Standard Deviation 10 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 1 | 41 pounds | Standard Deviation 10 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 1 | 46 pounds | Standard Deviation 9 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 3 | 43 pounds | Standard Deviation 7 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 2 | 40 pounds | Standard Deviation 10 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 5 | 45 pounds | Standard Deviation 13 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 5 | 85 pounds | Standard Deviation 19 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 3 | 43 pounds | Standard Deviation 11 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 2 | 47 pounds | Standard Deviation 9 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 5 | 50 pounds | Standard Deviation 11 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 4 | 43 pounds | Standard Deviation 13 |
| Monthly Cycled Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 1 | 73 pounds | Standard Deviation 10 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 4 | 41 pounds | Standard Deviation 12 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 5 | 38 pounds | Standard Deviation 11 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 1 | 37 pounds | Standard Deviation 4 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 2 | 44 pounds | Standard Deviation 10 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 1 | 67 pounds | Standard Deviation 15 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 3 | 44 pounds | Standard Deviation 14 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extensuion Month 4 | 82 pounds | Standard Deviation 14 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 4 | 44 pounds | Standard Deviation 12 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Month 5 | 45 pounds | Standard Deviation 10 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 2 | 78 pounds | Standard Deviation 12 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 1 | 41 pounds | Standard Deviation 8 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 5 | 83 pounds | Standard Deviation 17 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 2 | 48 pounds | Standard Deviation 11 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Baseline | 32 pounds | Standard Deviation 9 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Extension Baseline | 38 pounds | Standard Deviation 9 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 3 | 48 pounds | Standard Deviation 14 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Baseline | 40 pounds | Standard Deviation 9 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Month 3 | 76 pounds | Standard Deviation 21 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Extension Baseline | 66 pounds | Standard Deviation 16 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 1 | 34 pounds | Standard Deviation 8 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 4 | 50 pounds | Standard Deviation 12 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 2 | 39 pounds | Standard Deviation 9 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Arm Curl Month 3 | 37 pounds | Standard Deviation 13 |
| Continuous Testosterone | Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months | Leg Curl Month 5 | 51 pounds | Standard Deviation 12 |
Secondary
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months
Time frame: 5 months
Population: All subjects who completed the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-B1 Baseline | 0.14 pg/mL | Standard Deviation 0.1 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-B1 Five Months | 0.20833 pg/mL | Standard Deviation 0.22221 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-2 Baseline | 1.32 pg/mL | Standard Deviation 1.18655 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-2 Five Months | 2.84 pg/mL | Standard Deviation 1.99008 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-5 Baseline | 0.6 pg/mL | Standard Deviation 0.71529 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-5 Five Months | 0.705 pg/mL | Standard Deviation 1.32898 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-6 Baseline | 5.68375 pg/mL | Standard Deviation 6.78293 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-6 Five months | 5.05 pg/mL | Standard Deviation 6.0643 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-7 Baseline | 8.78 pg/mL | Standard Deviation 10.4076 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-7 Five Months | 7.68 pg/mL | Standard Deviation 10.898 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-8 Baseline | 4.5575 pg/mL | Standard Deviation 2.67011 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-8 Five months | 4.3225 pg/mL | Standard Deviation 2.0872 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-10 Baseline | 22.6363 pg/mL | Standard Deviation 41.8883 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-10 Five Months | 25.4525 pg/mL | Standard Deviation 41.4135 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-12 Baseline | 7.075 pg/mL | Standard Deviation 12.3805 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-12 Five Months | 10.902 pg/mL | Standard Deviation 17.4143 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-13 baseline | 37.045 pg/mL | Standard Deviation 51.9229 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-13 Five Months | 43.465 pg/mL | Standard Deviation 61.0587 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IFN gamma Baseline | 10.115 pg/mL | Standard Deviation 15.7219 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IFN gamma Five Months | 36.05 pg/mL | Standard Deviation 68.7309 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | GM-CSF Baseline | 1.52429 pg/mL | Standard Deviation 2.46286 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | GM-CSF Five Months | 2.27857 pg/mL | Standard Deviation 3.19199 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | TNF alpha Baseline | 9.0175 pg/mL | Standard Deviation 4.60793 |
| Placebo | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | TNF alpha Five Months | 8.14 pg/mL | Standard Deviation 3.95778 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | GM-CSF Five Months | 1.312 pg/mL | Standard Deviation 0.88649 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-B1 Baseline | 0.475 pg/mL | Standard Deviation 0.76767 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-10 Baseline | 11.2588 pg/mL | Standard Deviation 8.19838 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-13 baseline | 23.33 pg/mL | Standard Deviation 48.7029 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-B1 Five Months | 3.19 pg/mL | Standard Deviation 3.24643 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-8 Baseline | 6.66375 pg/mL | Standard Deviation 4.50933 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | GM-CSF Baseline | 2.4 pg/mL | Standard Deviation 2.58639 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-2 Baseline | 3.19 pg/mL | Standard Deviation 3.24643 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-10 Five Months | 8.34143 pg/mL | Standard Deviation 3.65748 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | TNF alpha Baseline | 10.0863 pg/mL | Standard Deviation 4.51058 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-2 Five Months | 1.45333 pg/mL | Standard Deviation 0.94076 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-7 Five Months | 23.1888 pg/mL | Standard Deviation 52.3705 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-13 Five Months | 12.72 pg/mL | Standard Deviation 17.2687 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-5 Baseline | 0.79 pg/mL | Standard Deviation 0.76783 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-12 Baseline | 4.242 pg/mL | Standard Deviation 4.07052 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-8 Five months | 4.06286 pg/mL | Standard Deviation 1.76795 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-7 Baseline | 11.9688 pg/mL | Standard Deviation 16.2135 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-5 Five Months | 0.32286 pg/mL | Standard Deviation 0.30065 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-12 Five Months | 2.66 pg/mL | Standard Deviation 3.7993 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | TNF alpha Five Months | 8.1529 pg/mL | Standard Deviation 3.70965 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-6 Baseline | 4.90857 pg/mL | Standard Deviation 6.43277 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IFN gamma Baseline | 4.58 pg/mL | Standard Deviation 7.63943 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-6 Five months | 6.487 pg/mL | Standard Deviation 178.673 |
| Monthly Cycled Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IFN gamma Five Months | 1.758 pg/mL | Standard Deviation 1.98486 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-6 Five months | 13.89 pg/mL | Standard Deviation 28.8691 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-7 Baseline | 5.19875 pg/mL | Standard Deviation 2.84198 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-7 Five Months | 16.2763 pg/mL | Standard Deviation 19.6011 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-8 Baseline | 8.45625 pg/mL | Standard Deviation 11.836 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IFN gamma Five Months | 36.822 pg/mL | Standard Deviation 69.571 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-8 Five months | 11.8025 pg/mL | Standard Deviation 20.6936 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | TNF alpha Baseline | 13.215 pg/mL | Standard Deviation 10.1743 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-10 Baseline | 109.446 pg/mL | Standard Deviation 240.088 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-10 Five Months | 135.64 pg/mL | Standard Deviation 265.7 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | GM-CSF Baseline | 7.94875 pg/mL | Standard Deviation 16.6389 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-12 Baseline | 35.3583 pg/mL | Standard Deviation 56.0444 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | TNF alpha Five Months | 15.4138 pg/mL | Standard Deviation 13.0438 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-12 Five Months | 58.4217 pg/mL | Standard Deviation 86.8424 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-B1 Baseline | 1.44143 pg/mL | Standard Deviation 2.04769 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-B1 Five Months | 2.538 pg/mL | Standard Deviation 3.33404 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-13 baseline | 60.2125 pg/mL | Standard Deviation 102.473 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-2 Baseline | 2.538 pg/mL | Standard Deviation 3.33404 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | GM-CSF Five Months | 14.965 pg/mL | Standard Deviation 37.1713 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-2 Five Months | 3.862 pg/mL | Standard Deviation 5.90798 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-6 Baseline | 10.4025 pg/mL | Standard Deviation 20.5897 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-5 Baseline | 1.41875 pg/mL | Standard Deviation 1.92013 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-13 Five Months | 73.674 pg/mL | Standard Deviation 148.613 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IL-5 Five Months | 1.94125 pg/mL | Standard Deviation 3.46852 |
| Continuous Testosterone | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | IFN gamma Baseline | 23.425 pg/mL | Standard Deviation 28.8768 |
Secondary
Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Forearm Five Months | 0.61 gm/cm^2 | Standard Error 0.02 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Total Baseline | 1.12 gm/cm^2 | Standard Error 0.04 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lumbar Spine Five Months | 1.07 gm/cm^2 | Standard Error 0.07 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Forearm Baseline | 0.59 gm/cm^2 | Standard Error 0.02 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Total Five Months | 1.08 gm/cm^2 | Standard Error 0.07 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Pelvis baseline | 1.46 gm/cm^2 | Standard Error 0.16 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lumbar Spine Baseline | 1.06 gm/cm^2 | Standard Error 0.07 |
| Placebo | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Pelvis Five Months | 1.28 gm/cm^2 | Standard Error 0.14 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lumbar Spine Baseline | 1.00 gm/cm^2 | Standard Error 0.05 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Total Baseline | 1.07 gm/cm^2 | Standard Error 0.05 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Forearm Baseline | 0.59 gm/cm^2 | Standard Error 0.02 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Forearm Five Months | 0.59 gm/cm^2 | Standard Error 0.03 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Pelvis baseline | 1.15 gm/cm^2 | Standard Error 0.04 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Pelvis Five Months | 1.14 gm/cm^2 | Standard Error 0.04 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lumbar Spine Five Months | 1.00 gm/cm^2 | Standard Error 0.05 |
| Monthly Cycled Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Total Five Months | 1.05 gm/cm^2 | Standard Error 0.05 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Forearm Five Months | 0.62 gm/cm^2 | Standard Error 0.03 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Total Baseline | 1.12 gm/cm^2 | Standard Error 0.05 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Total Five Months | 1.14 gm/cm^2 | Standard Error 0.03 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lumbar Spine Baseline | 1.16 gm/cm^2 | Standard Error 0.04 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Lumbar Spine Five Months | 1.19 gm/cm^2 | Standard Error 0.06 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Pelvis baseline | 1.27 gm/cm^2 | Standard Error 0.04 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Pelvis Five Months | 1.28 gm/cm^2 | Standard Error 0.06 |
| Continuous Testosterone | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | Forearm Baseline | 0.61 gm/cm^2 | Standard Error 0.02 |
Secondary
Changes in Serum Markers of Bone Turnover.
Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include: Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Serum Markers of Bone Turnover. | Osteocalcin Five Months | 8 nM BCE (Bone Collagen Equivalents) | Standard Error 0.5 |
| Placebo | Changes in Serum Markers of Bone Turnover. | iPTH Baseline | 40 nM BCE (Bone Collagen Equivalents) | Standard Error 0.3 |
| Placebo | Changes in Serum Markers of Bone Turnover. | BAP Five Months | 21 nM BCE (Bone Collagen Equivalents) | Standard Error 1.3 |
| Placebo | Changes in Serum Markers of Bone Turnover. | TRAP5b Baseline | 2 nM BCE (Bone Collagen Equivalents) | Standard Error 0.6 |
| Placebo | Changes in Serum Markers of Bone Turnover. | iPTH Five Months | 45 nM BCE (Bone Collagen Equivalents) | Standard Error 7 |
| Placebo | Changes in Serum Markers of Bone Turnover. | Osteocalcin Baseline | 8 nM BCE (Bone Collagen Equivalents) | Standard Error 0.2 |
| Placebo | Changes in Serum Markers of Bone Turnover. | NTX Five Months | 13 nM BCE (Bone Collagen Equivalents) | Standard Error 1.1 |
| Placebo | Changes in Serum Markers of Bone Turnover. | Calcitonin Baseline | 3 nM BCE (Bone Collagen Equivalents) | Standard Error 0.4 |
| Placebo | Changes in Serum Markers of Bone Turnover. | TRAP5b Five Months | 2 nM BCE (Bone Collagen Equivalents) | Standard Error 0.6 |
| Placebo | Changes in Serum Markers of Bone Turnover. | BAP Baseline | 22 nM BCE (Bone Collagen Equivalents) | Standard Error 1.5 |
| Placebo | Changes in Serum Markers of Bone Turnover. | Calcitonin Five months | 3 nM BCE (Bone Collagen Equivalents) | Standard Error 0.4 |
| Placebo | Changes in Serum Markers of Bone Turnover. | NTX Baseline | 12 nM BCE (Bone Collagen Equivalents) | Standard Error 1.3 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | Calcitonin Five months | 4 nM BCE (Bone Collagen Equivalents) | Standard Error 0.5 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | NTX Baseline | 14 nM BCE (Bone Collagen Equivalents) | Standard Error 1.4 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | NTX Five Months | 11 nM BCE (Bone Collagen Equivalents) | Standard Error 0.7 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | TRAP5b Baseline | 2 nM BCE (Bone Collagen Equivalents) | Standard Error 0.6 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | BAP Five Months | 19 nM BCE (Bone Collagen Equivalents) | Standard Error 1.9 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | TRAP5b Five Months | 2 nM BCE (Bone Collagen Equivalents) | Standard Error 0.6 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | iPTH Baseline | 37 nM BCE (Bone Collagen Equivalents) | Standard Error 6 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | Osteocalcin Five Months | 8 nM BCE (Bone Collagen Equivalents) | Standard Error 0.5 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | iPTH Five Months | 28 nM BCE (Bone Collagen Equivalents) | Standard Error 3 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | Osteocalcin Baseline | 8 nM BCE (Bone Collagen Equivalents) | Standard Error 0.6 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | Calcitonin Baseline | 4 nM BCE (Bone Collagen Equivalents) | Standard Error 0.6 |
| Monthly Cycled Testosterone | Changes in Serum Markers of Bone Turnover. | BAP Baseline | 20 nM BCE (Bone Collagen Equivalents) | Standard Error 2.3 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | iPTH Five Months | 60 nM BCE (Bone Collagen Equivalents) | Standard Error 15 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | Osteocalcin Baseline | 9 nM BCE (Bone Collagen Equivalents) | Standard Error 0.7 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | Osteocalcin Five Months | 7 nM BCE (Bone Collagen Equivalents) | Standard Error 0.8 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | BAP Baseline | 17 nM BCE (Bone Collagen Equivalents) | Standard Error 1.5 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | BAP Five Months | 15 nM BCE (Bone Collagen Equivalents) | Standard Error 1.7 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | iPTH Baseline | 53 nM BCE (Bone Collagen Equivalents) | Standard Error 10 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | TRAP5b Five Months | 1 nM BCE (Bone Collagen Equivalents) | Standard Error 0.3 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | Calcitonin Baseline | 4 nM BCE (Bone Collagen Equivalents) | Standard Error 1.3 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | Calcitonin Five months | 3 nM BCE (Bone Collagen Equivalents) | Standard Error 0.3 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | NTX Baseline | 15 nM BCE (Bone Collagen Equivalents) | Standard Error 1.9 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | NTX Five Months | 11 nM BCE (Bone Collagen Equivalents) | Standard Error 1.5 |
| Continuous Testosterone | Changes in Serum Markers of Bone Turnover. | TRAP5b Baseline | 2 nM BCE (Bone Collagen Equivalents) | Standard Error 0.4 |