Trial Outcomes & Findings for Cycled Testosterone Replacement Study (NCT NCT00957528)
NCT ID: NCT00957528
Last Updated: 2012-09-10
Results Overview
Lean body mass is expressed in grams as calculated by Hologic DEXA.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
5 months
Results posted on
2012-09-10
Participant Flow
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).
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.
Participant milestones
| Measure |
Placebo
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Cycled Testosterone Replacement Study
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=9 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=9 Participants
Weekly testosterone treatment for a duration of 5 months
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Age Continuous
|
65.4 years
STANDARD_DEVIATION 3.22 • n=93 Participants
|
71.6 years
STANDARD_DEVIATION 7.78 • n=4 Participants
|
73.3 years
STANDARD_DEVIATION 7.54 • n=27 Participants
|
70.1 years
STANDARD_DEVIATION 6.18 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
9 participants
n=4 Participants
|
9 participants
n=27 Participants
|
26 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 5 MonthsPopulation: Subjects who completed the entire treatment protocol
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 Participants
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
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
|
0.06 Percent per hour (%/hr)
Standard Deviation 0.01
|
0.06 Percent per hour (%/hr)
Standard Deviation 0.01
|
|
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 0.020
|
0.094 Percent per hour (%/hr)
Standard Deviation 0.014
|
0.101 Percent per hour (%/hr)
Standard Deviation 0.043
|
PRIMARY outcome
Timeframe: 5 monthsMaximum 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).
Outcome measures
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 Participants
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
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
|
50 pounds
Standard Deviation 11
|
51 pounds
Standard Deviation 12
|
|
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
|
73 pounds
Standard Deviation 10
|
67 pounds
Standard Deviation 15
|
|
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
|
39 pounds
Standard Deviation 10
|
32 pounds
Standard Deviation 9
|
|
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
|
41 pounds
Standard Deviation 14
|
38 pounds
Standard Deviation 9
|
|
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
|
44 pounds
Standard Deviation 7
|
40 pounds
Standard Deviation 9
|
|
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
|
73 pounds
Standard Deviation 15
|
66 pounds
Standard Deviation 16
|
|
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
|
41 pounds
Standard Deviation 10
|
34 pounds
Standard Deviation 8
|
|
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
|
40 pounds
Standard Deviation 10
|
39 pounds
Standard Deviation 9
|
|
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
|
43 pounds
Standard Deviation 11
|
37 pounds
Standard Deviation 13
|
|
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
|
43 pounds
Standard Deviation 13
|
41 pounds
Standard Deviation 12
|
|
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
|
45 pounds
Standard Deviation 13
|
38 pounds
Standard Deviation 11
|
|
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
|
41 pounds
Standard Deviation 10
|
37 pounds
Standard Deviation 4
|
|
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
|
42 pounds
Standard Deviation 9
|
44 pounds
Standard Deviation 10
|
|
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
|
43 pounds
Standard Deviation 7
|
44 pounds
Standard Deviation 14
|
|
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
|
44 pounds
Standard Deviation 8
|
44 pounds
Standard Deviation 12
|
|
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
|
45 pounds
Standard Deviation 8
|
45 pounds
Standard Deviation 10
|
|
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
|
46 pounds
Standard Deviation 9
|
41 pounds
Standard Deviation 8
|
|
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
|
47 pounds
Standard Deviation 9
|
48 pounds
Standard Deviation 11
|
|
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
|
43 pounds
Standard Deviation 20
|
48 pounds
Standard Deviation 14
|
|
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
|
50 pounds
Standard Deviation 10
|
50 pounds
Standard Deviation 12
|
|
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
|
77 pounds
Standard Deviation 16
|
78 pounds
Standard Deviation 12
|
|
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
|
80 pounds
Standard Deviation 14
|
76 pounds
Standard Deviation 21
|
|
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
|
79 pounds
Standard Deviation 16
|
82 pounds
Standard Deviation 14
|
|
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
|
85 pounds
Standard Deviation 19
|
83 pounds
Standard Deviation 17
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: All subjects who successfully completed the five month protocol.
Lean body mass is expressed in grams as calculated by Hologic DEXA.
Outcome measures
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 Participants
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Lean Body Mass Baseline
|
62344 grams
Standard Deviation 10368
|
57101 grams
Standard Deviation 6671.5
|
57746 grams
Standard Deviation 6485.1
|
|
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
|
59155.4 grams
Standard Deviation 6890.9
|
60469.3 grams
Standard Deviation 6555.92
|
|
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
|
56787.8 grams
Standard Deviation 6444.16
|
62680.1 grams
Standard Deviation 4034.41
|
|
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
|
59186 grams
Standard Deviation 6267.63
|
61167.3 grams
Standard Deviation 7530.43
|
|
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
|
59838.6 grams
Standard Deviation 7010.73
|
61436.6 grams
Standard Deviation 6997.17
|
|
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
|
58846.9 grams
Standard Deviation 6995.48
|
60871.4 grams
Standard Deviation 6840.45
|
SECONDARY outcome
Timeframe: 5 monthsBone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months
Outcome measures
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 Participants
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
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
|
1.15 gm/cm^2
Standard Error 0.04
|
1.27 gm/cm^2
Standard Error 0.04
|
|
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
|
1.07 gm/cm^2
Standard Error 0.05
|
1.12 gm/cm^2
Standard Error 0.05
|
|
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
|
1.05 gm/cm^2
Standard Error 0.05
|
1.14 gm/cm^2
Standard Error 0.03
|
|
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
|
1.00 gm/cm^2
Standard Error 0.05
|
1.16 gm/cm^2
Standard Error 0.04
|
|
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
|
1.00 gm/cm^2
Standard Error 0.05
|
1.19 gm/cm^2
Standard Error 0.06
|
|
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
|
1.14 gm/cm^2
Standard Error 0.04
|
1.28 gm/cm^2
Standard Error 0.06
|
|
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
|
0.59 gm/cm^2
Standard Error 0.02
|
0.61 gm/cm^2
Standard Error 0.02
|
|
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
|
0.59 gm/cm^2
Standard Error 0.03
|
0.62 gm/cm^2
Standard Error 0.03
|
SECONDARY outcome
Timeframe: 5 monthsMeasures 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
Outcome measures
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 Participants
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
Changes in Serum Markers of Bone Turnover.
NTX Baseline
|
12 nM BCE (Bone Collagen Equivalents)
Standard Error 1.3
|
14 nM BCE (Bone Collagen Equivalents)
Standard Error 1.4
|
15 nM BCE (Bone Collagen Equivalents)
Standard Error 1.9
|
|
Changes in Serum Markers of Bone Turnover.
NTX Five Months
|
13 nM BCE (Bone Collagen Equivalents)
Standard Error 1.1
|
11 nM BCE (Bone Collagen Equivalents)
Standard Error 0.7
|
11 nM BCE (Bone Collagen Equivalents)
Standard Error 1.5
|
|
Changes in Serum Markers of Bone Turnover.
TRAP5b Baseline
|
2 nM BCE (Bone Collagen Equivalents)
Standard Error 0.6
|
2 nM BCE (Bone Collagen Equivalents)
Standard Error 0.6
|
2 nM BCE (Bone Collagen Equivalents)
Standard Error 0.4
|
|
Changes in Serum Markers of Bone Turnover.
TRAP5b Five Months
|
2 nM BCE (Bone Collagen Equivalents)
Standard Error 0.6
|
2 nM BCE (Bone Collagen Equivalents)
Standard Error 0.6
|
1 nM BCE (Bone Collagen Equivalents)
Standard Error 0.3
|
|
Changes in Serum Markers of Bone Turnover.
Osteocalcin Baseline
|
8 nM BCE (Bone Collagen Equivalents)
Standard Error 0.2
|
8 nM BCE (Bone Collagen Equivalents)
Standard Error 0.6
|
9 nM BCE (Bone Collagen Equivalents)
Standard Error 0.7
|
|
Changes in Serum Markers of Bone Turnover.
Osteocalcin Five Months
|
8 nM BCE (Bone Collagen Equivalents)
Standard Error 0.5
|
8 nM BCE (Bone Collagen Equivalents)
Standard Error 0.5
|
7 nM BCE (Bone Collagen Equivalents)
Standard Error 0.8
|
|
Changes in Serum Markers of Bone Turnover.
BAP Baseline
|
22 nM BCE (Bone Collagen Equivalents)
Standard Error 1.5
|
20 nM BCE (Bone Collagen Equivalents)
Standard Error 2.3
|
17 nM BCE (Bone Collagen Equivalents)
Standard Error 1.5
|
|
Changes in Serum Markers of Bone Turnover.
BAP Five Months
|
21 nM BCE (Bone Collagen Equivalents)
Standard Error 1.3
|
19 nM BCE (Bone Collagen Equivalents)
Standard Error 1.9
|
15 nM BCE (Bone Collagen Equivalents)
Standard Error 1.7
|
|
Changes in Serum Markers of Bone Turnover.
iPTH Baseline
|
40 nM BCE (Bone Collagen Equivalents)
Standard Error .3
|
37 nM BCE (Bone Collagen Equivalents)
Standard Error 6
|
53 nM BCE (Bone Collagen Equivalents)
Standard Error 10
|
|
Changes in Serum Markers of Bone Turnover.
iPTH Five Months
|
45 nM BCE (Bone Collagen Equivalents)
Standard Error 7
|
28 nM BCE (Bone Collagen Equivalents)
Standard Error 3
|
60 nM BCE (Bone Collagen Equivalents)
Standard Error 15
|
|
Changes in Serum Markers of Bone Turnover.
Calcitonin Baseline
|
3 nM BCE (Bone Collagen Equivalents)
Standard Error 0.4
|
4 nM BCE (Bone Collagen Equivalents)
Standard Error 0.6
|
4 nM BCE (Bone Collagen Equivalents)
Standard Error 1.3
|
|
Changes in Serum Markers of Bone Turnover.
Calcitonin Five months
|
3 nM BCE (Bone Collagen Equivalents)
Standard Error 0.4
|
4 nM BCE (Bone Collagen Equivalents)
Standard Error 0.5
|
3 nM BCE (Bone Collagen Equivalents)
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: All subjects who completed the protocol.
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
Outcome measures
| Measure |
Placebo
n=8 Participants
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 Participants
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 Participants
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-7 Baseline
|
8.78 pg/mL
Standard Deviation 10.4076
|
11.9688 pg/mL
Standard Deviation 16.2135
|
5.19875 pg/mL
Standard Deviation 2.84198
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IFN gamma Five Months
|
36.05 pg/mL
Standard Deviation 68.7309
|
1.758 pg/mL
Standard Deviation 1.98486
|
36.822 pg/mL
Standard Deviation 69.571
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-B1 Baseline
|
0.14 pg/mL
Standard Deviation 0.1
|
0.475 pg/mL
Standard Deviation 0.76767
|
1.44143 pg/mL
Standard Deviation 2.04769
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-B1 Five Months
|
0.20833 pg/mL
Standard Deviation 0.22221
|
3.19 pg/mL
Standard Deviation 3.24643
|
2.538 pg/mL
Standard Deviation 3.33404
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-2 Baseline
|
1.32 pg/mL
Standard Deviation 1.18655
|
3.19 pg/mL
Standard Deviation 3.24643
|
2.538 pg/mL
Standard Deviation 3.33404
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-2 Five Months
|
2.84 pg/mL
Standard Deviation 1.99008
|
1.45333 pg/mL
Standard Deviation 0.94076
|
3.862 pg/mL
Standard Deviation 5.90798
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-5 Baseline
|
0.6 pg/mL
Standard Deviation 0.71529
|
0.79 pg/mL
Standard Deviation 0.76783
|
1.41875 pg/mL
Standard Deviation 1.92013
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-5 Five Months
|
0.705 pg/mL
Standard Deviation 1.32898
|
0.32286 pg/mL
Standard Deviation 0.30065
|
1.94125 pg/mL
Standard Deviation 3.46852
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-6 Baseline
|
5.68375 pg/mL
Standard Deviation 6.78293
|
4.90857 pg/mL
Standard Deviation 6.43277
|
10.4025 pg/mL
Standard Deviation 20.5897
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-6 Five months
|
5.05 pg/mL
Standard Deviation 6.0643
|
6.487 pg/mL
Standard Deviation 178.673
|
13.89 pg/mL
Standard Deviation 28.8691
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-7 Five Months
|
7.68 pg/mL
Standard Deviation 10.898
|
23.1888 pg/mL
Standard Deviation 52.3705
|
16.2763 pg/mL
Standard Deviation 19.6011
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-8 Baseline
|
4.5575 pg/mL
Standard Deviation 2.67011
|
6.66375 pg/mL
Standard Deviation 4.50933
|
8.45625 pg/mL
Standard Deviation 11.836
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-8 Five months
|
4.3225 pg/mL
Standard Deviation 2.0872
|
4.06286 pg/mL
Standard Deviation 1.76795
|
11.8025 pg/mL
Standard Deviation 20.6936
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-10 Baseline
|
22.6363 pg/mL
Standard Deviation 41.8883
|
11.2588 pg/mL
Standard Deviation 8.19838
|
109.446 pg/mL
Standard Deviation 240.088
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-10 Five Months
|
25.4525 pg/mL
Standard Deviation 41.4135
|
8.34143 pg/mL
Standard Deviation 3.65748
|
135.64 pg/mL
Standard Deviation 265.7
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-12 Baseline
|
7.075 pg/mL
Standard Deviation 12.3805
|
4.242 pg/mL
Standard Deviation 4.07052
|
35.3583 pg/mL
Standard Deviation 56.0444
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-12 Five Months
|
10.902 pg/mL
Standard Deviation 17.4143
|
2.66 pg/mL
Standard Deviation 3.7993
|
58.4217 pg/mL
Standard Deviation 86.8424
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-13 baseline
|
37.045 pg/mL
Standard Deviation 51.9229
|
23.33 pg/mL
Standard Deviation 48.7029
|
60.2125 pg/mL
Standard Deviation 102.473
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IL-13 Five Months
|
43.465 pg/mL
Standard Deviation 61.0587
|
12.72 pg/mL
Standard Deviation 17.2687
|
73.674 pg/mL
Standard Deviation 148.613
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
IFN gamma Baseline
|
10.115 pg/mL
Standard Deviation 15.7219
|
4.58 pg/mL
Standard Deviation 7.63943
|
23.425 pg/mL
Standard Deviation 28.8768
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
GM-CSF Baseline
|
1.52429 pg/mL
Standard Deviation 2.46286
|
2.4 pg/mL
Standard Deviation 2.58639
|
7.94875 pg/mL
Standard Deviation 16.6389
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
GM-CSF Five Months
|
2.27857 pg/mL
Standard Deviation 3.19199
|
1.312 pg/mL
Standard Deviation 0.88649
|
14.965 pg/mL
Standard Deviation 37.1713
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
TNF alpha Baseline
|
9.0175 pg/mL
Standard Deviation 4.60793
|
10.0863 pg/mL
Standard Deviation 4.51058
|
13.215 pg/mL
Standard Deviation 10.1743
|
|
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
TNF alpha Five Months
|
8.14 pg/mL
Standard Deviation 3.95778
|
8.1529 pg/mL
Standard Deviation 3.70965
|
15.4138 pg/mL
Standard Deviation 13.0438
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Monthly Cycled Testosterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Testosterone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Weekly placebo treatment for a duration of 5 months.
|
Monthly Cycled Testosterone
n=8 participants at risk
A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
|
Continuous Testosterone
n=8 participants at risk
Weekly testosterone treatment for a duration of 5 months
|
|---|---|---|---|
|
Vascular disorders
Saphenous vein clot
|
12.5%
1/8
|
0.00%
0/8
|
12.5%
1/8
|
|
Nervous system disorders
vertigo
|
12.5%
1/8
|
0.00%
0/8
|
12.5%
1/8
|
Additional Information
Randall Urban, M.D., Professor of Medicine
The University of Texas Medical Branch at Galveston
Phone: 409- 772-1176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place