Trial Outcomes & Findings for Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception (NCT NCT00351819)
NCT ID: NCT00351819
Last Updated: 2017-06-28
Results Overview
BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Week14 after intervention
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Androgel (Testosterone Gel)
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
|
Overall Study
COMPLETED
|
36
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
| Measure |
Androgel (Testosterone Gel)
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Elevated PSA
|
1
|
1
|
|
Overall Study
Traumatic ankle fracture
|
1
|
0
|
|
Overall Study
Unprofessional behavior
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Incarcerated
|
0
|
1
|
|
Overall Study
Enrolled in another trial
|
0
|
1
|
Baseline Characteristics
Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Adiponectin outcomes.
Baseline characteristics by cohort
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 9 • n=36 Participants
|
50 years
STANDARD_DEVIATION 6 • n=29 Participants
|
49 years
STANDARD_DEVIATION 8 • n=65 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=36 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=36 Participants
|
29 Participants
n=29 Participants
|
65 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
29 participants
n=29 Participants
|
65 participants
n=65 Participants
|
|
Body Mass Index (BMI)
|
32.0 kg/m2
STANDARD_DEVIATION 7.0 • n=36 Participants
|
33.4 kg/m2
STANDARD_DEVIATION 8.0 • n=29 Participants
|
32.6 kg/m2
STANDARD_DEVIATION 7.4 • n=65 Participants
|
|
Opioid dose (morphine equivalent)
|
114 mg
STANDARD_DEVIATION 176 • n=36 Participants
|
76 mg
STANDARD_DEVIATION 139 • n=29 Participants
|
97 mg
STANDARD_DEVIATION 161 • n=65 Participants
|
|
Time on opioids
|
54 months
STANDARD_DEVIATION 48 • n=36 Participants
|
40 months
STANDARD_DEVIATION 54 • n=29 Participants
|
48 months
STANDARD_DEVIATION 50 • n=65 Participants
|
|
Total testosterone
|
221 ng/dL
STANDARD_DEVIATION 87 • n=36 Participants
|
237 ng/dL
STANDARD_DEVIATION 97 • n=29 Participants
|
228 ng/dL
STANDARD_DEVIATION 91 • n=65 Participants
|
|
Free testosterone
|
44.1 pg/mL
STANDARD_DEVIATION 22.6 • n=36 Participants
|
43.6 pg/mL
STANDARD_DEVIATION 19.3 • n=29 Participants
|
43.9 pg/mL
STANDARD_DEVIATION 21.0 • n=65 Participants
|
|
Sex hormone binding globulin
|
39.3 nmol/L
STANDARD_DEVIATION 31.4 • n=36 Participants
|
37.7 nmol/L
STANDARD_DEVIATION 14.5 • n=29 Participants
|
38.6 nmol/L
STANDARD_DEVIATION 25.2 • n=65 Participants
|
|
Luteinizing hormone
|
2.8 U/L
STANDARD_DEVIATION 1.9 • n=36 Participants
|
3.8 U/L
STANDARD_DEVIATION 2.4 • n=29 Participants
|
3.2 U/L
STANDARD_DEVIATION 2.2 • n=65 Participants
|
|
TNF-Alpha
|
1.8 pg/mL
STANDARD_DEVIATION 0.6 • n=36 Participants
|
2.2 pg/mL
STANDARD_DEVIATION 2.7 • n=29 Participants
|
2.0 pg/mL
STANDARD_DEVIATION 1.9 • n=65 Participants
|
|
IL-6
|
2.6 pg/mL
STANDARD_DEVIATION 2.8 • n=36 Participants
|
2.8 pg/mL
STANDARD_DEVIATION 2.9 • n=29 Participants
|
2.7 pg/mL
STANDARD_DEVIATION 2.8 • n=65 Participants
|
|
Hemoglobin
|
15 g/dL
n=36 Participants
|
14 g/dL
n=29 Participants
|
15 g/dL
n=65 Participants
|
|
Hematocrit
|
44 %
n=36 Participants
|
43 %
n=29 Participants
|
43 %
n=65 Participants
|
|
Brief Pain Inventory (BPI) questionnaire
Total
|
11.5 units on a scale
STANDARD_DEVIATION 3.2 • n=36 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 3.1 • n=29 Participants
|
11.0 units on a scale
STANDARD_DEVIATION 3.2 • n=65 Participants
|
|
Brief Pain Inventory (BPI) questionnaire
Severity
|
5.7 units on a scale
STANDARD_DEVIATION 1.5 • n=36 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.7 • n=29 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.6 • n=65 Participants
|
|
Brief Pain Inventory (BPI) questionnaire
Interference
|
5.8 units on a scale
STANDARD_DEVIATION 2.2 • n=36 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 1.8 • n=29 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 2.1 • n=65 Participants
|
|
Algometer-induced pressure pain
Trapezius
|
341 kPa/cm2
STANDARD_DEVIATION 116 • n=36 Participants
|
353 kPa/cm2
STANDARD_DEVIATION 197 • n=29 Participants
|
347 kPa/cm2
STANDARD_DEVIATION 157 • n=65 Participants
|
|
Algometer-induced pressure pain
Thumb
|
369 kPa/cm2
STANDARD_DEVIATION 125 • n=36 Participants
|
383 kPa/cm2
STANDARD_DEVIATION 185 • n=29 Participants
|
375 kPa/cm2
STANDARD_DEVIATION 155 • n=65 Participants
|
|
Weighted pinprick stimulator-induced mechanical pain
First stimulus
|
12.0 watt
STANDARD_DEVIATION 13.0 • n=36 Participants
|
8.0 watt
STANDARD_DEVIATION 7.4 • n=29 Participants
|
10.2 watt
STANDARD_DEVIATION 11.0 • n=65 Participants
|
|
Weighted pinprick stimulator-induced mechanical pain
10th stimulus
|
27.0 watt
STANDARD_DEVIATION 20.6 • n=36 Participants
|
18.6 watt
STANDARD_DEVIATION 19.5 • n=29 Participants
|
23.2 watt
STANDARD_DEVIATION 20.4 • n=65 Participants
|
|
Ice water-induced cold pain and its after-sensation
Cold pain tolerance
|
40.1 seconds
STANDARD_DEVIATION 33.4 • n=36 Participants
|
53.3 seconds
STANDARD_DEVIATION 51.3 • n=29 Participants
|
46.1 seconds
STANDARD_DEVIATION 42.7 • n=65 Participants
|
|
Ice water-induced cold pain and its after-sensation
Cold pain after sensation: 30s
|
16.7 seconds
STANDARD_DEVIATION 19.2 • n=36 Participants
|
13.8 seconds
STANDARD_DEVIATION 18.0 • n=29 Participants
|
15.4 seconds
STANDARD_DEVIATION 18.5 • n=65 Participants
|
|
Sexual Function as assessed by International Index of Erectile Function (IIEF)
Total score
|
44.6 units on a scale
STANDARD_DEVIATION 19.0 • n=36 Participants
|
41.1 units on a scale
STANDARD_DEVIATION 21.7 • n=29 Participants
|
43.0 units on a scale
STANDARD_DEVIATION 20.2 • n=65 Participants
|
|
Sexual Function as assessed by International Index of Erectile Function (IIEF)
Erectile function
|
18.8 units on a scale
STANDARD_DEVIATION 9.2 • n=36 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 10.6 • n=29 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 9.8 • n=65 Participants
|
|
Sexual Function as assessed by International Index of Erectile Function (IIEF)
Orgasmic function
|
6.5 units on a scale
STANDARD_DEVIATION 3.5 • n=36 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 3.6 • n=29 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 3.6 • n=65 Participants
|
|
Sexual Function as assessed by International Index of Erectile Function (IIEF)
Sexual desire
|
5.5 units on a scale
STANDARD_DEVIATION 2.5 • n=36 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 2.1 • n=29 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 2.3 • n=65 Participants
|
|
Sexual Function as assessed by International Index of Erectile Function (IIEF)
Intercourse satisfaction
|
8.2 units on a scale
STANDARD_DEVIATION 4.6 • n=36 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 5.6 • n=29 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 5.1 • n=65 Participants
|
|
Sexual Function as assessed by International Index of Erectile Function (IIEF)
Overall satisfaction
|
4.9 units on a scale
STANDARD_DEVIATION 2.5 • n=36 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.9 • n=29 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.7 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Physical functioning
|
41 units on a scale
STANDARD_DEVIATION 22 • n=36 Participants
|
38 units on a scale
STANDARD_DEVIATION 25 • n=29 Participants
|
39 units on a scale
STANDARD_DEVIATION 23 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Bodily pain
|
56 units on a scale
STANDARD_DEVIATION 15 • n=36 Participants
|
55 units on a scale
STANDARD_DEVIATION 17 • n=29 Participants
|
56 units on a scale
STANDARD_DEVIATION 16 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Role limitations due to physical health problems
|
10 units on a scale
STANDARD_DEVIATION 24 • n=36 Participants
|
18 units on a scale
STANDARD_DEVIATION 31 • n=29 Participants
|
13 units on a scale
STANDARD_DEVIATION 27 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Role limitations due to emotional problems
|
39 units on a scale
STANDARD_DEVIATION 45 • n=36 Participants
|
40 units on a scale
STANDARD_DEVIATION 45 • n=29 Participants
|
39 units on a scale
STANDARD_DEVIATION 44 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Emotional well-being
|
60 units on a scale
STANDARD_DEVIATION 16 • n=36 Participants
|
59 units on a scale
STANDARD_DEVIATION 17 • n=29 Participants
|
60 units on a scale
STANDARD_DEVIATION 16 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Social functioning
|
53 units on a scale
STANDARD_DEVIATION 13 • n=36 Participants
|
54 units on a scale
STANDARD_DEVIATION 15 • n=29 Participants
|
54 units on a scale
STANDARD_DEVIATION 14 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
Energry/fatigue
|
37 units on a scale
STANDARD_DEVIATION 18 • n=36 Participants
|
37 units on a scale
STANDARD_DEVIATION 18 • n=29 Participants
|
37 units on a scale
STANDARD_DEVIATION 18 • n=65 Participants
|
|
Health Quality of Life (QoL) as assessed by Short Form 36 (SF-36)
General health perceptions
|
54 units on a scale
STANDARD_DEVIATION 14 • n=36 Participants
|
51 units on a scale
STANDARD_DEVIATION 14 • n=29 Participants
|
52 units on a scale
STANDARD_DEVIATION 14 • n=65 Participants
|
|
Body composition measured by dual energy x-ray absorptiometry
Lean mass
|
57.4 kg
STANDARD_DEVIATION 7.8 • n=36 Participants
|
60.1 kg
STANDARD_DEVIATION 6.9 • n=29 Participants
|
58.6 kg
STANDARD_DEVIATION 7.5 • n=65 Participants
|
|
Body composition measured by dual energy x-ray absorptiometry
Fat mass
|
27.0 kg
STANDARD_DEVIATION 9.7 • n=36 Participants
|
26.8 kg
STANDARD_DEVIATION 9.5 • n=29 Participants
|
26.9 kg
STANDARD_DEVIATION 9.5 • n=65 Participants
|
|
Body composition measured by dual energy x-ray absorptiometry
Total mass
|
84.4 kg
STANDARD_DEVIATION 16.1 • n=36 Participants
|
86.8 kg
STANDARD_DEVIATION 13.8 • n=29 Participants
|
85.5 kg
STANDARD_DEVIATION 15.0 • n=65 Participants
|
|
Body composition measured by dual energy x-ray absorptiometry
Appendicular lean mass
|
27.4 kg
STANDARD_DEVIATION 4.0 • n=36 Participants
|
28.6 kg
STANDARD_DEVIATION 4.2 • n=29 Participants
|
27.9 kg
STANDARD_DEVIATION 4.1 • n=65 Participants
|
|
Body composition measured by dual energy x-ray absorptiometry
Appendicular fat mass
|
11.7 kg
STANDARD_DEVIATION 4.9 • n=36 Participants
|
11.9 kg
STANDARD_DEVIATION 5.1 • n=29 Participants
|
11.8 kg
STANDARD_DEVIATION 5.0 • n=65 Participants
|
|
Body composition measured by dual energy x-ray absorptiometry
Appendicular total mass
|
38.3 kg
STANDARD_DEVIATION 7.8 • n=36 Participants
|
39.4 kg
STANDARD_DEVIATION 7.0 • n=29 Participants
|
38.8 kg
STANDARD_DEVIATION 7.4 • n=65 Participants
|
|
Lipid profile
Total cholesterol
|
4.6 mmol/L
STANDARD_DEVIATION 1.1 • n=36 Participants
|
5.2 mmol/L
STANDARD_DEVIATION 1.2 • n=29 Participants
|
4.9 mmol/L
STANDARD_DEVIATION 1.2 • n=65 Participants
|
|
Lipid profile
LDL
|
2.8 mmol/L
STANDARD_DEVIATION 1.0 • n=36 Participants
|
3.2 mmol/L
STANDARD_DEVIATION 0.9 • n=29 Participants
|
3.0 mmol/L
STANDARD_DEVIATION 1.0 • n=65 Participants
|
|
Lipid profile
HDL
|
1.0 mmol/L
STANDARD_DEVIATION 0.3 • n=36 Participants
|
1.1 mmol/L
STANDARD_DEVIATION 0.4 • n=29 Participants
|
1.0 mmol/L
STANDARD_DEVIATION 0.3 • n=65 Participants
|
|
Lipid profile
Triglycerides
|
2.0 mmol/L
STANDARD_DEVIATION 1.6 • n=36 Participants
|
2.0 mmol/L
STANDARD_DEVIATION 1.2 • n=29 Participants
|
2.0 mmol/L
STANDARD_DEVIATION 1.4 • n=65 Participants
|
|
HbA1c
|
5.7 percentage of glycossylated hemoglobin
STANDARD_DEVIATION 0.01 • n=36 Participants
|
6.2 percentage of glycossylated hemoglobin
STANDARD_DEVIATION 0.02 • n=29 Participants
|
5.9 percentage of glycossylated hemoglobin
STANDARD_DEVIATION 0.01 • n=65 Participants
|
|
Glucose levels in OGTT
Fasting glucose
|
5.2 mmol/L
STANDARD_DEVIATION 0.7 • n=36 Participants
|
5.6 mmol/L
STANDARD_DEVIATION 2.6 • n=29 Participants
|
5.3 mmol/L
STANDARD_DEVIATION 1.8 • n=65 Participants
|
|
Glucose levels in OGTT
OGTT 1-h glucose
|
8.4 mmol/L
STANDARD_DEVIATION 2.9 • n=36 Participants
|
8.0 mmol/L
STANDARD_DEVIATION 2.8 • n=29 Participants
|
8.2 mmol/L
STANDARD_DEVIATION 2.8 • n=65 Participants
|
|
Glucose levels in OGTT
OGTT 2-h glucose
|
6.5 mmol/L
STANDARD_DEVIATION 1.9 • n=36 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 2.0 • n=29 Participants
|
6.3 mmol/L
STANDARD_DEVIATION 1.9 • n=65 Participants
|
|
Insulin levels in OGTT
Fasting insulin
|
64 pmol/L
STANDARD_DEVIATION 66 • n=36 Participants
|
100 pmol/L
STANDARD_DEVIATION 174 • n=29 Participants
|
80 pmol/L
STANDARD_DEVIATION 126 • n=65 Participants
|
|
Insulin levels in OGTT
OGTT 1-h insulin
|
300 pmol/L
STANDARD_DEVIATION 306 • n=36 Participants
|
416 pmol/L
STANDARD_DEVIATION 325 • n=29 Participants
|
351 pmol/L
STANDARD_DEVIATION 317 • n=65 Participants
|
|
Insulin levels in OGTT
OGTT 2-h insulin
|
246 pmol/L
STANDARD_DEVIATION 242 • n=36 Participants
|
311 pmol/L
STANDARD_DEVIATION 293 • n=29 Participants
|
275 pmol/L
STANDARD_DEVIATION 266 • n=65 Participants
|
|
HOMA IR
|
2.1 HOMA IR score
STANDARD_DEVIATION 2.1 • n=36 Participants
|
3.3 HOMA IR score
STANDARD_DEVIATION 5.8 • n=29 Participants
|
2.6 HOMA IR score
STANDARD_DEVIATION 4.2 • n=65 Participants
|
|
Adiponectin
|
4.9 ug/mL
STANDARD_DEVIATION 2.7 • n=36 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Adiponectin outcomes.
|
4.5 ug/mL
STANDARD_DEVIATION 1.7 • n=28 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Adiponectin outcomes.
|
4.7 ug/mL
STANDARD_DEVIATION 2.3 • n=64 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Adiponectin outcomes.
|
|
Leptin
|
16 ug/L
STANDARD_DEVIATION 12 • n=36 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Leptin outcomes.
|
18 ug/L
STANDARD_DEVIATION 17 • n=28 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Leptin outcomes.
|
17 ug/L
STANDARD_DEVIATION 14 • n=64 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on Leptin outcomes.
|
|
C-reactive protein
|
3.1 mg/L
STANDARD_DEVIATION 3.5 • n=36 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on C-reactive protein outcomes.
|
2.7 mg/L
STANDARD_DEVIATION 2.3 • n=28 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on C-reactive protein outcomes.
|
2.9 mg/L
STANDARD_DEVIATION 3.0 • n=64 Participants • Of the completers, 64 men (36 in the testosterone arm and 28 in the placebo arm) had pre and post-intervention data on C-reactive protein outcomes.
|
|
Pain catastrophizing scale (PCS)
Composite score
|
26 units on a scale
STANDARD_DEVIATION 11 • n=33 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
27 units on a scale
STANDARD_DEVIATION 11 • n=29 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
27 units on a scale
STANDARD_DEVIATION 11 • n=62 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
|
Pain catastrophizing scale (PCS)
Rumination score
|
9.5 units on a scale
STANDARD_DEVIATION 4.0 • n=33 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
9.6 units on a scale
STANDARD_DEVIATION 3.0 • n=29 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
9.5 units on a scale
STANDARD_DEVIATION 3.6 • n=62 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
|
Pain catastrophizing scale (PCS)
Magnification score
|
4.7 units on a scale
STANDARD_DEVIATION 3.2 • n=33 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
5.1 units on a scale
STANDARD_DEVIATION 2.9 • n=29 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
4.9 units on a scale
STANDARD_DEVIATION 3.1 • n=62 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
|
Pain catastrophizing scale (PCS)
Helplessness score
|
11.5 units on a scale
STANDARD_DEVIATION 5.3 • n=33 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
11.6 units on a scale
STANDARD_DEVIATION 5.1 • n=29 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
11.6 units on a scale
STANDARD_DEVIATION 5.2 • n=62 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on PCS outcomes.
|
|
Insomnia severity index (ISI)
|
11.9 units on a scale
STANDARD_DEVIATION 4.7 • n=33 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on ISI outcomes.
|
11.6 units on a scale
STANDARD_DEVIATION 4.4 • n=29 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on ISI outcomes.
|
11.8 units on a scale
STANDARD_DEVIATION 4.5 • n=62 Participants • Of the completers, 62 men (33 in the testosterone arm and 29 in the placebo arm) had pre and post-intervention data on ISI outcomes.
|
PRIMARY outcome
Timeframe: Week14 after interventionPopulation: All available data expressed as absolute values at week 14.
BPI is a self-administered questionnaire that measuring chronic pain. BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score assesses the severity of pain on a continuous scale from 0 (no pain) to 10 (severe pain). The pain interference score corresponds to the item on pain interference, ranging from 0 (does not interfere) to 10(completely interferes). The total score is the sum of the pain severity score and pain interference score, ranging from 0(no pain) to 20 (severe and completely interfered pain).
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Brief Pain Inventory (BPI) at Week 14
Total score
|
10.2 units on a scale
Standard Deviation 3.8
|
9.7 units on a scale
Standard Deviation 3.3
|
|
Brief Pain Inventory (BPI) at Week 14
Severity
|
5.3 units on a scale
Standard Deviation 1.7
|
5.1 units on a scale
Standard Deviation 1.6
|
|
Brief Pain Inventory (BPI) at Week 14
Interference
|
5.0 units on a scale
Standard Deviation 2.3
|
4.7 units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Week 14 after interventionA digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Algometer-induced Pressure Pain at Week 14
Trapezius
|
379.4 kPa/cm2
Standard Deviation 194.7
|
315.9 kPa/cm2
Standard Deviation 151.6
|
|
Algometer-induced Pressure Pain at Week 14
Thumb
|
409.7 kPa/cm2
Standard Deviation 167.9
|
326.4 kPa/cm2
Standard Deviation 187.3
|
PRIMARY outcome
Timeframe: Week 14 after interventionWeighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14
First Stimulus
|
10.9 watts
Standard Deviation 8.4
|
11.7 watts
Standard Deviation 13.2
|
|
Weighted Pinprick Stimulator-induced Mechanical Pain at Week 14
10th Stimulus
|
21.9 watts
Standard Deviation 17.4
|
22.2 watts
Standard Deviation 23.5
|
PRIMARY outcome
Timeframe: Week 14 after interventionCold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Ice Water-induced Cold Pain and Its After-sensation at Week 14
Cold pain tolenrance
|
54.2 seconds
Standard Deviation 55.9
|
54.1 seconds
Standard Deviation 50.9
|
|
Ice Water-induced Cold Pain and Its After-sensation at Week 14
Cold pain after sensation: 30s
|
13.1 seconds
Standard Deviation 18.4
|
13.9 seconds
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Week14 after interventionPopulation: All available data expressed as absolute values at week 14.
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
Total score
|
51.3 units on a scale
Standard Deviation 17.5
|
47.1 units on a scale
Standard Deviation 23.1
|
|
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
Erectile function
|
21.7 units on a scale
Standard Deviation 7.9
|
19.2 units on a scale
Standard Deviation 10.8
|
|
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
Orgasmic funcion
|
7.7 units on a scale
Standard Deviation 2.9
|
6.4 units on a scale
Standard Deviation 3.4
|
|
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
Sexual desire
|
6.8 units on a scale
Standard Deviation 2.1
|
6.3 units on a scale
Standard Deviation 2.6
|
|
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
Intercourse satisfaction
|
9.1 units on a scale
Standard Deviation 5.2
|
9.0 units on a scale
Standard Deviation 5.4
|
|
Sexual Functioning as Assessed by International Index of Erectile Function (IIEF) at Week 14
Overall satisfaction
|
6.1 units on a scale
Standard Deviation 2.5
|
6.1 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Physical functioning
|
42 units on a scale
Standard Deviation 19
|
42 units on a scale
Standard Deviation 24
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Bodily pain
|
62 units on a scale
Standard Deviation 21
|
61 units on a scale
Standard Deviation 17
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Role limitations due to physical health problems
|
23 units on a scale
Standard Deviation 35
|
22 units on a scale
Standard Deviation 29
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Role limitations due to emotional problems
|
56 units on a scale
Standard Deviation 42
|
37 units on a scale
Standard Deviation 43
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Emotional well-being
|
64 units on a scale
Standard Deviation 16
|
63 units on a scale
Standard Deviation 15
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Social functioning
|
57 units on a scale
Standard Deviation 14
|
54 units on a scale
Standard Deviation 13
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
Energy-fatigue
|
44 units on a scale
Standard Deviation 17
|
40 units on a scale
Standard Deviation 18
|
|
Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) at Week 14
General health perceptions
|
55 units on a scale
Standard Deviation 12
|
52 units on a scale
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Values at week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
PCS questionnaire measures self-assessment of pain catastrophizing. This questionnaire consists of 13 items on past painful experiences and rate on 5-point scales ranging from 0 (not at all) to 4 (all the time). The PCS yields three subscale scores assessing rumination (range 0-16), magnification (range 0-12), helplessness (range 0-24), and a composite score (sum of three domains, ranging 0-52). Higher score represents worse painful experiences.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS) at Week 14
Rumination score
|
7.1 units on a scale
Standard Deviation 4.1
|
7.6 units on a scale
Standard Deviation 3.1
|
|
Pain Catastrophizing Scale (PCS) at Week 14
Magnification score
|
3.7 units on a scale
Standard Deviation 2.8
|
4.1 units on a scale
Standard Deviation 2.4
|
|
Pain Catastrophizing Scale (PCS) at Week 14
Composite score
|
20 units on a scale
Standard Deviation 12
|
21 units on a scale
Standard Deviation 10
|
|
Pain Catastrophizing Scale (PCS) at Week 14
Helplessness score
|
9.2 units on a scale
Standard Deviation 5.8
|
8.4 units on a scale
Standard Deviation 4.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Total testosterone was measured in a CDC-certified laboratory using an LC-MS/MS method with a sensitivity of 2 ng/dL.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Total Testosterone Values at Week 14
|
790 ng/dL
Standard Deviation 544
|
328 ng/dL
Standard Deviation 185
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Free testosterone was calculated using a law of mass action equation.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Free Testosterone Values at Week 14
|
189 pg/mL
Standard Deviation 152
|
65 pg/mL
Standard Deviation 36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Sex hormone binding globulin was measured using immunofluorometric assays, with limits of quantification of 2.5 nmol/L.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Sex Hormone Binding Globulin (SHBG) at Week 14
|
34.6 nmol/L
Standard Deviation 18.2
|
35.0 nmol/L
Standard Deviation 14.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Luteinizing hormone was measured using immunofluorometric assays, with limits of quantification of 0.05 U/L.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Luteinizing Hormone Values at Week 14
|
1.6 U/L
Standard Deviation 2.2
|
3.5 U/L
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
The pathophysiology of pain is measured by the proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor alpha (TNF-Alpha).
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Inflammatory Cytokines at Week 14
IL-6
|
2.4 pg/mL
Standard Deviation 2.1
|
2.6 pg/mL
Standard Deviation 2.7
|
|
Inflammatory Cytokines at Week 14
TNF-Alpha
|
1.9 pg/mL
Standard Deviation 1.0
|
2.1 pg/mL
Standard Deviation 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Body composition was measured using dual-energy X-ray absorptiometry scan.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Body Composition at Week 14
Lean mass
|
57.8 kg
Standard Deviation 7.5
|
60.9 kg
Standard Deviation 5.9
|
|
Body Composition at Week 14
Fat mass
|
25.7 kg
Standard Deviation 8.7
|
27.9 kg
Standard Deviation 9.7
|
|
Body Composition at Week 14
Total mass
|
83.5 kg
Standard Deviation 14.8
|
88.7 kg
Standard Deviation 12.8
|
|
Body Composition at Week 14
Appendicular lean mass
|
27.9 kg
Standard Deviation 4.1
|
29.4 kg
Standard Deviation 3.7
|
|
Body Composition at Week 14
Appendicular fat mass
|
11.4 kg
Standard Deviation 4.7
|
12.1 kg
Standard Deviation 4.7
|
|
Body Composition at Week 14
Appendicular total mass
|
38.6 kg
Standard Deviation 7.9
|
40.8 kg
Standard Deviation 6.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Serum total cholesterol, triglycerides and high-density lipoprotein (HDL) cholesterol levels were measured by enzymatic assays and standardized to the CDC using the Lipid Research Clinic protocol. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=27 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Lipid Profile at Week 14
Total cholesterol
|
4.8 mmol/L
Standard Deviation 1.2
|
5.1 mmol/L
Standard Deviation 1.1
|
|
Lipid Profile at Week 14
LDL
|
2.9 mmol/L
Standard Deviation 1.0
|
3.1 mmol/L
Standard Deviation 1.0
|
|
Lipid Profile at Week 14
HDL
|
1.0 mmol/L
Standard Deviation 0.4
|
1.1 mmol/L
Standard Deviation 0.4
|
|
Lipid Profile at Week 14
Triglycerides
|
1.8 mmol/L
Standard Deviation 1.0
|
1.9 mmol/L
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=28 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
HbA1c at Week 14
|
5.7 percentage of glycosylated hemogobin
Standard Deviation 0.01
|
6.1 percentage of glycosylated hemogobin
Standard Deviation 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The plasma glucose level were analyzed at baseline and at 60 and 120 min after glucose loading.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=25 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14
Fasting glucose
|
5.2 mmol/L
Standard Deviation 1.4
|
5.6 mmol/L
Standard Deviation 1.4
|
|
Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14
OGTT 1-h glucose
|
8.0 mmol/L
Standard Deviation 3.4
|
8.3 mmol/L
Standard Deviation 2.4
|
|
Glucose Level in Oral Glucose Tolerance Test (OGTT) at Week 14
OGTT 2-h glucose
|
6.7 mmol/L
Standard Deviation 3.2
|
6.1 mmol/L
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Values at week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
All participants underwent 75-g oral glucose tolerance test (OGTT) after a 12-h fast, The insulin level were analyzed at baseline and at 60 and 120 min after glucose loading.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=25 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14
Fasting insulin
|
70 pmol/L
Standard Deviation 88
|
110 pmol/L
Standard Deviation 149
|
|
Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14
OGTT 1-h insulin
|
279 pmol/L
Standard Deviation 181
|
407 pmol/L
Standard Deviation 318
|
|
Insulin Level in Oral Glucose Tolerance Test (OGTT) at Week 14
OGTT 2-h insulin
|
231 pmol/L
Standard Deviation 210
|
325 pmol/L
Standard Deviation 275
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Insulin resistance was calculated using the homeostatic model assessment (HOMA) index: glucose \* insulin / 22.5.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=25 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
HOMA IR Score at Week 14
|
2.5 HOMA IR score
Standard Deviation 3.6
|
4.2 HOMA IR score
Standard Deviation 5.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Total adiponectin was measured using an RIA kit with an interassay CV of 6.9-9.3% and an intra-assay CV of 1.8-6.2% (Millipore).
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=28 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Adiponectin at Week 14
|
4.8 ug/mL
Standard Deviation 3.0
|
4.7 ug/mL
Standard Deviation 2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
Leptin levels were measured using ELISA with an interassay CV of 2.6% to 6.2% and in intra-assay CV of 2.6% to 4.6% (Millipore, Billerica, MA, USA).
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=35 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=28 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Leptin at Week 14
|
16 ug/L
Standard Deviation 12
|
21 ug/L
Standard Deviation 21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
High-sensitivity C-reactive protein (Alpco Diagnostics) was measured using a high-sensitivity sandwich ELISA with an intra-assay CV of 5.6%
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=36 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=28 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
C-reactive Protein (CRP) at Week 14
|
4.2 mg/L
Standard Deviation 4.4
|
3.4 mg/L
Standard Deviation 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 14 after interventionPopulation: All available data expressed as absolute values at week 14.
ISI is comprised of 7 items assesses a participant's perception of insomnia. Each item is rated on a 5-point scale from 0 (none) to 4 (very severe). Scores from the questions are summed to assign a total score ranging from 0 to 28, where higher score represents worse insomnia problem.
Outcome measures
| Measure |
Androgel (Testosterone Gel)
n=33 Participants
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=29 Participants
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Insomnia Severity Index (ISI) at Week 14
|
10.8 units on a scale
Standard Deviation 5.2
|
11.1 units on a scale
Standard Deviation 5.1
|
Adverse Events
Androgel (Testosterone Gel)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Androgel (Testosterone Gel)
n=43 participants at risk
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=41 participants at risk
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/43
|
0.00%
0/41
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/43
|
2.4%
1/41
|
|
Surgical and medical procedures
Wrist arthrodesis
|
0.00%
0/43
|
2.4%
1/41
|
Other adverse events
| Measure |
Androgel (Testosterone Gel)
n=43 participants at risk
Testosterone replacement therapy
Androgel (testosterone gel): 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
Placebo
n=41 participants at risk
Placebo gel
Placebo: 5g gel, applied once daily to the upper arms, upper back or shoulders.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.6%
5/43
|
9.8%
4/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
4/43
|
12.2%
5/41
|
|
Nervous system disorders
Headache
|
4.7%
2/43
|
7.3%
3/41
|
|
General disorders
Fever
|
7.0%
3/43
|
0.00%
0/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place