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. 2011 Mar 21;34(4):828–837. doi: 10.2337/dc10-1233

Table 2.

Mean values for primary and secondary end points at baseline and months 6 and 12 (ITT population, last observation carried forward)

All patients
 MetS patients
 Type 2 diabetic patients
Testosterone Placebo Testosterone Placebo Testosterone Placebo
Glucose metabolism
Fasting serum insulin (pmol/L)
 Baseline 151.68 ± 153.26 137.65 ± 147.46 162.17 ± 166.29 153.76 ± 163.02 145.08 ± 158.55 126.19 ± 109.17
  n 102 105 82 81 64 65
 Phase 1: Month 6 124.59 ± 98.65 128.20 ± 99.76 125.08 ± 86.89 135.50 ± 104.45 121.61 ± 102.01 136.40 ± 117.44
  n 101 101 83 80 65 63
 Phase 2: Month 12 134.25 ± 108.57 126.89 ± 94.31 135.50 ± 100.92 131.33 ± 98.47 130.91 ± 113.99 131.96 ± 104.30
  n 103 101 85 80 65 63
FPG (mmol/L)
 Baseline 7.94 ± 2.99 7.59 ± 2.62 7.60 ± 2.41 7.60 ± 2.71 9.05 ± 3.18 8.49 ± 2.84
  n 104 107 84 83 67 67
 Phase 1: Month 6 7.84 ± 3.03 7.99 ± 2.86 7.67 ± 2.82 7.88 ± 2.99 8.91 ± 3.31 9.09 ± 2.97
  n 102 101 84 80 65 63
 Phase 2: Month 12 7.97 ± 3.45 8.14 ± 3.19 7.74 ± 3.25 8.05 ± 3.41 9.18 ± 3.75 9.35 ± 3.46
  n 102 101 84 80 65 63
HOMA-B†
 Baseline 104.8 ± 77.5 99.9 ± 75.8 110.5 ± 78.3 104.7 ± 74.7 83.3 ± 67.0 84.1 ± 74.0
  n 99 105 80 81 64 66
 Phase 1: Month 6 100.7 ± 78.9 98.3 ± 72.7 103.9 ± 79.4 106.0 ± 74.9 79.4 ± 66.0 75.3 ± 58.2
  n 105 108 86 84 67 67
 Phase 2: Month 12 102.0 ± 79.5 99.4 ± 70.8 105.1 ± 80.1 105.4 ± 70.2 79.1 ± 65.4 79.3 ± 66.5
  n 105 109 86 85 67 68
Lipid parameters
Lpa (µmol/L)
 Baseline 1.44 ± 1.56 1.40 ± 1.17 1.50 ± 1.64 1.42 ± 1.21 1.36 ± 1.36 1.37 ± 1.28
  n 98* 102 81** 79 62 64
 Phase 1: Month 6 1.22 ± 1.19 1.59 ± 1.80 1.22 ± 1.20 1.49 ± 1.65 1.20 ± 1.16 1.61 ± 2.15
  n 96* 98 80** 79 62 60
 Phase 2: Month 9 1.39 ± 1.39 1.90 ± 1.94 1.37 ± 1.43 1.77 ± 1.58 1.51 ± 1.52 1.96 ± 2.34
  n 51* 56 43 44 35 35
 Phase 2: Month 12 1.26 ± 1.22 1.62 ± 1.82 1.26 ± 1.24 1.49 ± 1.38 1.29 ± 1.26 1.65 ± 2.19
  n 99 100 83** 80 63 61
TC (mmol/L)
 Baseline 4.65 ± 1.18 4.87 ± 1.11 4.79 ± 1.22 4.98 ± 1.09 4.51 ± 1.17 4.55 ± 1.01
  n 106 108 86 84 67 67
 Phase 1: Month 6 4.52 ± 1.11 4.89 ± 1.13 4.56 ± 1.11 5.05 ± 1.13 4.44 ± 1.12 4.57 ± 0.97
  n 103 102 85** 81 66 63
 Phase 2: Month 9 4.55 ± 1.24 4.80 ± 1.12 4.61 ± 1.24 4.95 ± 1.10 4.32 ± 1.14 4.59 ± 1.13
  n 62 65 54 52 42 39
 Phase 2: Month 12 4.49 ± 1.16 4.77 ± 1.07 4.52 ± 1.17 4.88 ± 1.05 4.31 ± 1.05 4.52 ± 0.95
  n 104 102 86 81 66 63
LDL cholesterol (mmol/L)
 Baseline 2.78 ± 0.99 2.89 ± 0.96 2.89 ± 1.02 2.98 ± 0.95 2.61 ± 0.91 2.61 ± 0.82
  n 106 108 86 84 67 67
 Phase 1: Month 6 2.65 ± 0.91 2.85 ± 0.91 2.70 ± 0.95 2.99 ± 0.93 2.60 ± 0.85 2.55 ± 0.70
  n 103 102 85* 81 66 63
 Phase 2: Month 9 2.67 ± 1.01 2.77 ± 0.88 2.70 ± 1.01 2.90 ± 0.90 2.53 ± 0.93 2.51 ± 0.77
  n 62 65 54 52 42 39
 Phase 2: Month 12 2.59 ± 0.91 2.75 ± 0.89 2.62 ± 0.93 2.85 ± 0.91 2.49 ± 0.82 2.50 ± 0.70
  n 104 102 86 81 66 63
HDL cholesterol (mmol/L)
 Baseline 1.19 ± 0.30 1.23 ± 0.28 1.21 ± 0.31 1.21 ± 0.26 1.16 ± 0.31 1.23 ± 0.29
  n 106 108 86 84 67 67
 Phase 1: Month 6 1.12 ± 0.26* 1.21 ± 0.25 1.12 ± 0.24 1.20 ± 0.24 1.09 ± 0.27 1.21 ± 0.26
  n 103 102 85* 81 66* 63
 Phase 2: Month 9 1.14 ± 0.31 1.20 ± 0.27 1.14 ± 0.28 1.18 ± 0.27 1.12 ± 0.33 1.20 ± 0.27
  n 62 65 54* 52 42 39
 Phase 2: Month 12 1.14 ± 0.30 1.21 ± 0.26 1.14 ± 0.28 1.20 ± 0.25 1.09 ± 0.30 1.21 ± 0.27
  n 104 102 86 81 66 63
Triglycerides (mmol/L)
 Baseline 1.92 ± 1.36 2.10 ± 1.44 1.94 ± 1.42 2.21 ± 1.52 2.06 ± 1.58 2.05 ± 1.30
  n 106 108 86 84 67 67
 Phase 1: Month 6 1.93 ± 1.23 2.04 ± 1.28 1.92 ± 1.05 2.10 ± 1.34 1.98 ± 1.31 2.07 ± 1.30
  n 103 102 85 81 66 63
 Phase 2: Month 9 2.00 ± 1.21 2.23 ± 1.71 2.07 ± 1.26 2.29 ± 1.76 1.91 ± 0.98 2.36 ± 1.99
  n 62 65 54 52 42 39
 Phase 2: Month 12 1.90 ± 1.15 2.14 ± 1.49 1.91 ± 1.06 2.16 ± 1.54 1.90 ± 1.17 2.19 ± 1.49
  n 104 102 86 81 66 63
Abdominal obesity and body composition
Body fat (%)
 Baseline 33.60 ± 6.54 32.24 ± 6.33 33.99 ± 6.69 32.37 ± 6.17 33.58 ± 5.43 32.54 ± 6.55
  n 108 112 88 88 68 69
 Phase 1: Month 6 33.01 ± 6.83 32.31 ± 5.77 33.31 ± 6.82 32.43 ± 5.59 32.86 ± 5.92 32.33 ± 5.88
  n 94 98 78 78 61 62
 Phase 2: Month 12 32.81 ± 7.08 32.63 ± 5.57 33.08 ± 7.18 32.66 ± 5.51 32.69 ± 6.44 32.68 ± 5.71
  n 100 98 83 78 63 62
BMI (kg/m2)
 Baseline 32.87 ± 6.58 31.29 ± 5.44 33.27 ± 6.80 31.63 ± 5.07 32.76 ± 6.12 31.56 ± 5.87
   n 108 112 88 88 68 69
 Phase 1: Month 6 33.07 ± 6.96 31.45 ± 5.26 33.28 ± 7.28 31.67 ± 5.03 33.16 ± 6.35 31.70 ± 5.55
   n 97 99 80 79 62 62
 Phase 2: Month 12 32.90 ± 7.01 31.43 ± 5.27 33.17 ± 7.35 31.53 ± 5.07 32.92 ± 6.52 31.73 ± 5.57
   n 102 99 84 79 64 62
Waist circumference (cm)
 Baseline 112.7 ± 13.22 110.1 ± 13.77 113.3 ± 13.43 110.8 ± 12.65 112.7 ± 13.35 111.7 ± 15.23
  n 108 112 88 88 68 69
 Phase 1: Month 6 111.9 ± 13.64 110.2 ± 13.36 112.0 ± 13.62 110.3 ± 12.02 113.1 ± 13.57 111.8 ± 14.46
  n 96 99 80 79 61 62
 Phase 2: Month 12 111.6 ± 13.89 110.6 ± 13.96 112.0 ± 13.92 110.8 ± 12.52 111.9 ± 13.79 112.4 ± 15.52
  n 100 99 83 79 63* 62
Blood pressure
Systolic blood pressure (mmHg)
 Baseline 138.6 ± 17.30 136.7 ± 17.12 — — — —
  n 108 112
 Phase 2: Month 12 138.7 ± 15.15 134.9 ± 16.49 — — — —
  n 50 58
Diastolic blood pressure (mmHg)
 Baseline 82.5 ± 10.23 81.6 ± 9.50
  n 108 112
Phase 2: Month 12 82.8 ± 9.72 80.3 ± 9.80 — — — —
  n 50 58
Sexual dysfunction
IIEF total score
 Baseline 32.4 ± 18.47 32.8 ± 21.24 — — — —
  n 94 98
 Phase 1: Month 6 41.3 ± 19.97 39.3 ± 22.12 — — — —
  n 82* 81
 Phase 2: Month 12 40.9 ± 20.34 37.3 ± 22.08 — — — —
  n 88* 88
Erectile function domain score
 Baseline 12.0 ± 9.07 11.9 ± 10.02
  n 101 103
 Phase 1: Month 6 15.6 ± 9.53 15.1 ± 10.49 — — — —
  n 84 89
 Phase 2: Month 12 15.2 ± 9.71 14.4 ± 10.42 — — — —
  n 90 93
Orgasmic function domain score
 Baseline 4.6 ± 3.80 4.7 ± 4.20 — — —
  n 105 107
 Phase 1: Month 6 5.9 ± 3.89 5.8 ± 4.18 — — — —
  n 88 90
 Phase 2: Month 12 5.5 ± 3.91 5.3 ± 4.23 — — — —
  n 95 93
Sexual desire domain score
 Baseline 5.3 ± 2.13 5.6 ± 2.47 — — —
  n 105 106
 Phase 1: Month 6 6.5 ± 2.27 5.9 ± 2.38 — — — —
  n 89** 91
 Phase 2: Month 12 6.3 ± 2.21 5.8 ± 2.55 — — — —
  n 94** 95
Intercourse satisfaction domain score
 Baseline 4.7 ± 4.58 4.7 ± 4.84 — — — —
  n 106 108
 Phase 1: Month 6 6.2 ± 4.95 6.3 ± 4.99 — — — —
  n 88 91
 Phase 2: Month 12 6.4 ± 5.01 5.7 ± 4.89 — — — —
  n 94* 92
Overall sexual satisfaction domain score
 Baseline 4.7 ± 2.46 4.8 ± 2.68 — — — —
  n 96 99
 Phase 1: Month 6 6.0 ± 2.62 5.7 ± 2.81 — — — —
  n 85 89
 Phase 2: Month 12 5.9 ± 2.70 5.5 ± 2.73 — — — —
  n 91 94
AMS total score
 Baseline 40.6 ± 11.44 39.9 ± 11.46 — — — —
  n 88 96
 Phase 1: Month 6 37.1 ± 11.72 36.1 ± 10.60 — — — —
  n 80 86
 Phase 2: Month 12 36.4 ± 11.16 37.8 ± 11.57 — — — —
  n 89 92

Data are means ± SD or n.

*P < 0.05.

**P < 0.01 between groups.

†HOMA-B = (20 x FPI [mIU/L])/(FPG [mmol/L]−3.5) (calculated excluding FPG values ≤ 3.5 mmol/L [formula invalid] and atypical insulin values [≥249 pmol/L screening values substituted when baseline values unavailable]).