Trial Outcomes & Findings for 5-Alpha Reductase and Anabolic Effects of Testosterone (NCT NCT00475501)
NCT ID: NCT00475501
Last Updated: 2018-10-11
Results Overview
1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
baseline, 3 months, 6 months, 9 months, 12 months
Results posted on
2018-10-11
Participant Flow
Subjects were recruited between 7/2/2007 and 10/13/2010. Subjects responded to letters mailed to male patients aged 60 years or more who were seen at VA clinics.
Subjects were excluded if they failed brief cognitive testing (MiniCog), if serum testosterone \> 300 ng/dL or less and bio-testosterone \> 70 ng/dL, congestive heart failure, sleep apnea, hematocrit (HCT) \> 49%, prostate specific antigen (PSA) \> 2.6 ng/ml, were taking coumadin or had orthopedic limitations.
Participant milestones
| Measure |
Arm 1
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
|
Arm 2
finasteride
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
|
Arm 4
placebo
Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
17
|
16
|
|
Overall Study
COMPLETED
|
7
|
8
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5-Alpha Reductase and Anabolic Effects of Testosterone
Baseline characteristics by cohort
| Measure |
Testosterone Vehicle
n=14 Participants
125 mg testosterone enanthate/week i.m. daily placebo pill
|
Vehicle Finasteride
n=13 Participants
weekly vehicle injection 5 mg finasteride/day p.o.
|
Testosterone Finasteride
n=17 Participants
125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
|
Vehicle Placebo
n=16 Participants
weekly vehicle injection daily placebo pill
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
69.5 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
64.2 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
70.8 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
68.25 years
STANDARD_DEVIATION 8.29 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: per protocol
1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
1 Repetition Maximum (1-RM) Strength Testing
leg press baseline Kg
|
129.1 kg
Standard Error 9.08
|
109.4 kg
Standard Error 7.87
|
137.2 kg
Standard Error 5.8
|
118.8 kg
Standard Error 8.825
|
|
1 Repetition Maximum (1-RM) Strength Testing
leg press 3-months change kg
|
9.192 kg
Standard Error 1.978
|
-1.34 kg
Standard Error 3.126
|
9.679 kg
Standard Error 3.16
|
-2.44 kg
Standard Error 2.22
|
|
1 Repetition Maximum (1-RM) Strength Testing
leg press 6-months change kg
|
10.227 kg
Standard Error 1.66
|
-1.136 kg
Standard Error 4.095
|
13.778 kg
Standard Error 4.1
|
2.727 kg
Standard Error 3.66
|
|
1 Repetition Maximum (1-RM) Strength Testing
leg press 9-months change kg
|
14.416 kg
Standard Error 2.63
|
-5.55 kg
Standard Error 4.95
|
10.49 kg
Standard Error 3.1
|
2.02 kg
Standard Error 2.636
|
|
1 Repetition Maximum (1-RM) Strength Testing
leg press 12-months change kg
|
14.773 kg
Standard Error 7.03
|
0 kg
Standard Error 2.629
|
12.5 kg
Standard Error 3.88
|
1.515 kg
Standard Error 3.47
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsGrip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Grip Strength kg
grip strength baseline kg
|
17.0 kg
Standard Error 1.23
|
16.9 kg
Standard Error 1.28
|
18.2 kg
Standard Error 0.513
|
17.472 kg
Standard Error 0.8522
|
|
Grip Strength kg
change grip strength 3 month kg
|
1.66 kg
Standard Error .427
|
-0.045 kg
Standard Error 0.485
|
0.485 kg
Standard Error 0.447
|
0.212 kg
Standard Error 0.44
|
|
Grip Strength kg
change grip strength 6 month kg
|
2.02 kg
Standard Error 0.482
|
0.812 kg
Standard Error 1.357
|
1.00 kg
Standard Error 0.589
|
-0.035 kg
Standard Error 0.411
|
|
Grip Strength kg
change grip strength 9 month kg
|
1.558 kg
Standard Error 0.505
|
1.25 kg
Standard Error 0.555
|
1.331 kg
Standard Error 0.399
|
0.152 kg
Standard Error 0.415
|
|
Grip Strength kg
change grip strength 12 month kg
|
1.909 kg
Standard Error 0.249
|
1.477 kg
Standard Error 0.211
|
1.174 kg
Standard Error 0.302
|
0.72 kg
Standard Error 0.342
|
SECONDARY outcome
Timeframe: baseline, 12 monthsDual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems).
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Lumbar Spine L2-L4 Bone Mineral Density
L2-L4 spine BMD baseline gm/cc
|
1.03 gm/cc
Standard Error 0.041
|
1.02 gm/cc
Standard Error 0.032
|
0.99 gm/cc
Standard Error 0.0167
|
1.07 gm/cc
Standard Error 0.045
|
|
Lumbar Spine L2-L4 Bone Mineral Density
change L2-L4 spine BMD 12 month gm/cc
|
0.049 gm/cc
Standard Error 0.017
|
0.002 gm/cc
Standard Error 0.006
|
0.053 gm/cc
Standard Error 0.017
|
-0.020 gm/cc
Standard Error 0.011
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsGeriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment. The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Geriatric Depression Scale
depression baseline
|
2.38 units on a scale
Standard Error 0.49
|
3.08 units on a scale
Standard Error 1.09
|
4.93 units on a scale
Standard Error 2.76
|
2.13 units on a scale
Standard Error 0.48
|
|
Geriatric Depression Scale
depression 3 months
|
1.80 units on a scale
Standard Error 0.49
|
2.90 units on a scale
Standard Error 1.24
|
3.23 units on a scale
Standard Error 0.86
|
1.67 units on a scale
Standard Error 0.3
|
|
Geriatric Depression Scale
depression 6 months
|
1.5 units on a scale
Standard Error 0.48
|
2.22 units on a scale
Standard Error 1.30
|
5.0 units on a scale
Standard Error 1.33
|
1.62 units on a scale
Standard Error 0.5
|
|
Geriatric Depression Scale
depression 9 months
|
0.88 units on a scale
Standard Error 0.23
|
1.89 units on a scale
Standard Error 0.99
|
3.69 units on a scale
Standard Error 1.07
|
2.92 units on a scale
Standard Error 0.94
|
|
Geriatric Depression Scale
depression 12 months
|
3.33 units on a scale
Standard Error 1.38
|
2.88 units on a scale
Standard Error 1.42
|
3.73 units on a scale
Standard Error 1.18
|
1.83 units on a scale
Standard Error 0.373
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsRey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning. The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
Rey baseline
|
12.42 units on a scale
Standard Error 1.46
|
13.54 units on a scale
Standard Error 1.36
|
12.82 units on a scale
Standard Error 0.92
|
12.8 units on a scale
Standard Error 1.58
|
|
30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
Rey 3 month
|
16.68 units on a scale
Standard Error 2.25
|
12.85 units on a scale
Standard Error 1.57
|
16.27 units on a scale
Standard Error 1.6
|
12.5 units on a scale
Standard Error 1.5
|
|
30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
Rey 6 month
|
15.76 units on a scale
Standard Error 2.6
|
16.17 units on a scale
Standard Error 2.04
|
17.38 units on a scale
Standard Error 1.55
|
14 units on a scale
Standard Error 2.7
|
|
30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
Rey 9 month
|
15.25 units on a scale
Standard Error 3.06
|
15.17 units on a scale
Standard Error 2.27
|
18.08 units on a scale
Standard Error 1.39
|
15.55 units on a scale
Standard Error 2.45
|
|
30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test
Rey 12 month
|
16.86 units on a scale
Standard Error 2.91
|
15 units on a scale
Standard Error 2.56
|
19.27 units on a scale
Standard Error 1.98
|
16.45 units on a scale
Standard Error 2.77
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsTrail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Trail-Making Test, Part A
Trails A baseline
|
37.59 sec
Standard Error 3.58
|
46.42 sec
Standard Error 3.61
|
36.65 sec
Standard Error 2.24
|
44.0 sec
Standard Error 6.76
|
|
Trail-Making Test, Part A
Trails A 3 months
|
38.5 sec
Standard Error 5.24
|
42.1 sec
Standard Error 5.59
|
33.53 sec
Standard Error 1.83
|
44.33 sec
Standard Error 7.12
|
|
Trail-Making Test, Part A
Trails A 6 months
|
32.9 sec
Standard Error 3.91
|
39.0 sec
Standard Error 5.55
|
31.2 sec
Standard Error 2.1
|
36.92 sec
Standard Error 5.21
|
|
Trail-Making Test, Part A
Trails A 9 months
|
31.0 sec
Standard Error 4.48
|
38.56 sec
Standard Error 4.37
|
29.07 sec
Standard Error 1.73
|
43.17 sec
Standard Error 12.97
|
|
Trail-Making Test, Part A
Trails A 12 months
|
29.17 sec
Standard Error 6.47
|
40.0 sec
Standard Error 5.48
|
32.5 sec
Standard Error 2.98
|
43.75 sec
Standard Error 13.26
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsBenton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment. The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Benton Judgment of Line Orientation Test
Benton baseline
|
24.54 units on a scale
Standard Error 1.26
|
24.39 units on a scale
Standard Error 0.80
|
25.88 units on a scale
Standard Error 0.92
|
24.69 units on a scale
Standard Error 1.23
|
|
Benton Judgment of Line Orientation Test
Benton 3 months
|
25.00 units on a scale
Standard Error 0.73
|
25.40 units on a scale
Standard Error 1.38
|
25.07 units on a scale
Standard Error 1.09
|
25.67 units on a scale
Standard Error 1.17
|
|
Benton Judgment of Line Orientation Test
Benton 6 months
|
25.90 units on a scale
Standard Error 1.18
|
25.11 units on a scale
Standard Error 1.33
|
26.0 units on a scale
Standard Error 0.79
|
25.08 units on a scale
Standard Error 1.26
|
|
Benton Judgment of Line Orientation Test
Benton 9 months
|
25.38 units on a scale
Standard Error 1.48
|
23.89 units on a scale
Standard Error 1.23
|
25.79 units on a scale
Standard Error 0.81
|
24.92 units on a scale
Standard Error 1.75
|
|
Benton Judgment of Line Orientation Test
Benton 12 months
|
25.67 units on a scale
Standard Error 0.80
|
25.5 units on a scale
Standard Error 1.12
|
26.17 units on a scale
Standard Error 0.77
|
24.08 units on a scale
Standard Error 1.88
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsHematocrit was assessed as a part of routine blood analysis at the indicated time points.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Hematocrit
hematocrit baseline %
|
42.6 % volume
Standard Error 0.833
|
41.2 % volume
Standard Error 1.042
|
42.0 % volume
Standard Error 0.7
|
40.3 % volume
Standard Error 0.975
|
|
Hematocrit
change hematocrit 3 months %
|
3.6 % volume
Standard Error 1.007
|
0.611 % volume
Standard Error 1.143
|
4.593 % volume
Standard Error 0.627
|
-0.06 % volume
Standard Error 0.44
|
|
Hematocrit
change hematocrit 6 months %
|
4.044 % volume
Standard Error 0.94
|
0.557 % volume
Standard Error 0.758
|
4.331 % volume
Standard Error 0.7264
|
0.514 % volume
Standard Error 0.396
|
|
Hematocrit
change hematocrit 9 months %
|
4.071 % volume
Standard Error 1.303
|
0.63 % volume
Standard Error 1.36
|
3.38 % volume
Standard Error 0.6622
|
-0.155 % volume
Standard Error 0.52
|
|
Hematocrit
change hematocrit 12 months %
|
5.22 % volume
Standard Error 0.8498
|
-1.175 % volume
Standard Error 0.984
|
4.173 % volume
Standard Error 0.8498
|
-0.192 % volume
Standard Error 0.667
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsDietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide "Healthy Ways to Eat More Protein".
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Dietary Protein Intake
protein intake 9 months
|
1.15 gm/body weight (kg)
Standard Error 0.08
|
1.20 gm/body weight (kg)
Standard Error 0.30
|
1.26 gm/body weight (kg)
Standard Error 0.30
|
0.82 gm/body weight (kg)
Standard Error 0.09
|
|
Dietary Protein Intake
protein intake baseline
|
0.97 gm/body weight (kg)
Standard Error 0.10
|
1.06 gm/body weight (kg)
Standard Error 0.08
|
0.99 gm/body weight (kg)
Standard Error 0.13
|
1.00 gm/body weight (kg)
Standard Error 0.06
|
|
Dietary Protein Intake
protein intake 3 months
|
0.87 gm/body weight (kg)
Standard Error 0.16
|
0.94 gm/body weight (kg)
Standard Error 0.15
|
1.49 gm/body weight (kg)
Standard Error 0.18
|
1.12 gm/body weight (kg)
Standard Error 0.16
|
|
Dietary Protein Intake
protein intake 6 months
|
0.74 gm/body weight (kg)
Standard Error 0.07
|
1.27 gm/body weight (kg)
Standard Error 0.49
|
1.05 gm/body weight (kg)
Standard Error 0.18
|
0.93 gm/body weight (kg)
Standard Error 0.18
|
|
Dietary Protein Intake
protein intake 12 months n = 1,1,2,5
|
1.18 gm/body weight (kg)
Standard Error NA
insufficient data for standard deviation
|
0.74 gm/body weight (kg)
Standard Error NA
insufficient data for standard deviation
|
1.39 gm/body weight (kg)
Standard Error 0.60
|
1.05 gm/body weight (kg)
Standard Error 0.18
|
SECONDARY outcome
Timeframe: baseline, 6 month, 12 monthsTransrectal ultrasound sizing of prostate will be performed using the B\&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Transrectal Ultrasound Sizing of Prostate
postate volume baseline cc
|
26.4 cc
Standard Error 2.33
|
29.7 cc
Standard Error 3.395
|
37.1 cc
Standard Error 4.379
|
36.9 cc
Standard Error 3.9
|
|
Transrectal Ultrasound Sizing of Prostate
change prostate volume 6 months cc
|
7.626 cc
Standard Error 1.703
|
-1.984 cc
Standard Error 4.31
|
-3.927 cc
Standard Error 2.25
|
-1.474 cc
Standard Error 3.147
|
|
Transrectal Ultrasound Sizing of Prostate
change prostate volume 12 months cc
|
11.42 cc
Standard Error 3.9
|
-4.93 cc
Standard Error 3.3
|
-1.72 cc
Standard Error 1.596
|
-2.891 cc
Standard Error 2.57
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 9 months, 12 monthsLife Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction.
Outcome measures
| Measure |
Arm 1
n=14 Participants
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 2
n=13 Participants
finasteride
Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 Participants
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
Measurement of leg press strength, 1-RM
|
Arm 4
n=16 Participants
placebo
Measurement of leg press strength, 1-RM
|
|---|---|---|---|---|
|
Life Satisfaction
Life Satisfaction A baseline
|
13.83 points
Standard Error 1.01
|
12.08 points
Standard Error 1.65
|
11.35 points
Standard Error 1.11
|
12.69 points
Standard Error 1.08
|
|
Life Satisfaction
Life Satisfaction A 3 months
|
12.67 points
Standard Error 0.76
|
12.11 points
Standard Error 2.00
|
12.27 points
Standard Error 1.33
|
14.13 points
Standard Error 0.91
|
|
Life Satisfaction
Life Satisfaction A 6 months
|
13.70 points
Standard Error 1.05
|
14.44 points
Standard Error 1.65
|
11.20 points
Standard Error 1.59
|
13.54 points
Standard Error 1.26
|
|
Life Satisfaction
Life Satisfaction A 9 months
|
14.75 points
Standard Error 1.03
|
13.44 points
Standard Error 1.39
|
11.57 points
Standard Error 1.35
|
13.17 points
Standard Error 1.48
|
|
Life Satisfaction
Life Satisfaction A 12 months
|
15.17 points
Standard Error 1.11
|
12.5 points
Standard Error 1.91
|
12.17 points
Standard Error 1.80
|
13.83 points
Standard Error 1.38
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 4
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=14 participants at risk
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
|
Arm 2
n=13 participants at risk
finasteride
Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 participants at risk
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 4
n=16 participants at risk
placebo
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Paget's disease
|
7.1%
1/14 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
0.00%
0/14 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Vascular disorders
stroke
|
0.00%
0/14 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
sleep apnea
|
7.1%
1/14 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
death
|
0.00%
0/14 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Cardiac disorders
surgery for pre-existing heart condition
|
7.1%
1/14 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
Other adverse events
| Measure |
Arm 1
n=14 participants at risk
testosterone enanthate
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
|
Arm 2
n=13 participants at risk
finasteride
Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 3
n=17 participants at risk
testosterone enanthate + finasteride
Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks
Finasteride : 5 mg, oral, once/day, for 52 weeks
|
Arm 4
n=16 participants at risk
placebo
|
|---|---|---|---|---|
|
General disorders
elevated prostate specific antigen
|
0.00%
0/14 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
urinary symptoms
|
7.1%
1/14 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
5.9%
1/17 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Blood and lymphatic system disorders
elevated hematocrit
|
7.1%
1/14 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
Additional Information
Stephen Borst, Ph.D
Geriatric Research Education and Clinical Center
Phone: 352-374-6114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60