Table 2

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

All patientsMetS patientsType 2 diabetic patients
TestosteronePlaceboTestosteronePlaceboTestosteronePlacebo
Glucose metabolism
Fasting serum insulin (pmol/L)
 Baseline151.68 ± 153.26137.65 ± 147.46162.17 ± 166.29153.76 ± 163.02145.08 ± 158.55126.19 ± 109.17
  n10210582816465
 Phase 1: Month 6124.59 ± 98.65128.20 ± 99.76125.08 ± 86.89135.50 ± 104.45121.61 ± 102.01136.40 ± 117.44
  n10110183806563
 Phase 2: Month 12134.25 ± 108.57126.89 ± 94.31135.50 ± 100.92131.33 ± 98.47130.91 ± 113.99131.96 ± 104.30
  n10310185806563
FPG (mmol/L)
 Baseline7.94 ± 2.997.59 ± 2.627.60 ± 2.417.60 ± 2.719.05 ± 3.188.49 ± 2.84
  n10410784836767
 Phase 1: Month 67.84 ± 3.037.99 ± 2.867.67 ± 2.827.88 ± 2.998.91 ± 3.319.09 ± 2.97
  n10210184806563
 Phase 2: Month 127.97 ± 3.458.14 ± 3.197.74 ± 3.258.05 ± 3.419.18 ± 3.759.35 ± 3.46
  n10210184806563
HOMA-B
 Baseline104.8 ± 77.599.9 ± 75.8110.5 ± 78.3104.7 ± 74.783.3 ± 67.084.1 ± 74.0
  n9910580816466
 Phase 1: Month 6100.7 ± 78.998.3 ± 72.7103.9 ± 79.4106.0 ± 74.979.4 ± 66.075.3 ± 58.2
  n10510886846767
 Phase 2: Month 12102.0 ± 79.599.4 ± 70.8105.1 ± 80.1105.4 ± 70.279.1 ± 65.479.3 ± 66.5
  n10510986856768
Lipid parameters
Lpa (µmol/L)
 Baseline1.44 ± 1.561.40 ± 1.171.50 ± 1.641.42 ± 1.211.36 ± 1.361.37 ± 1.28
  n98*10281**796264
 Phase 1: Month 61.22 ± 1.191.59 ± 1.801.22 ± 1.201.49 ± 1.651.20 ± 1.161.61 ± 2.15
  n96*9880**796260
 Phase 2: Month 91.39 ± 1.391.90 ± 1.941.37 ± 1.431.77 ± 1.581.51 ± 1.521.96 ± 2.34
  n51*5643443535
 Phase 2: Month 121.26 ± 1.221.62 ± 1.821.26 ± 1.241.49 ± 1.381.29 ± 1.261.65 ± 2.19
  n9910083**806361
TC (mmol/L)
 Baseline4.65 ± 1.184.87 ± 1.114.79 ± 1.224.98 ± 1.094.51 ± 1.174.55 ± 1.01
  n10610886846767
 Phase 1: Month 64.52 ± 1.114.89 ± 1.134.56 ± 1.115.05 ± 1.134.44 ± 1.124.57 ± 0.97
  n10310285**816663
 Phase 2: Month 94.55 ± 1.244.80 ± 1.124.61 ± 1.244.95 ± 1.104.32 ± 1.144.59 ± 1.13
  n626554524239
 Phase 2: Month 124.49 ± 1.164.77 ± 1.074.52 ± 1.174.88 ± 1.054.31 ± 1.054.52 ± 0.95
  n10410286816663
LDL cholesterol (mmol/L)
 Baseline2.78 ± 0.992.89 ± 0.962.89 ± 1.022.98 ± 0.952.61 ± 0.912.61 ± 0.82
  n10610886846767
 Phase 1: Month 62.65 ± 0.912.85 ± 0.912.70 ± 0.952.99 ± 0.932.60 ± 0.852.55 ± 0.70
  n10310285*816663
 Phase 2: Month 92.67 ± 1.012.77 ± 0.882.70 ± 1.012.90 ± 0.902.53 ± 0.932.51 ± 0.77
  n626554524239
 Phase 2: Month 122.59 ± 0.912.75 ± 0.892.62 ± 0.932.85 ± 0.912.49 ± 0.822.50 ± 0.70
  n10410286816663
HDL cholesterol (mmol/L)
 Baseline1.19 ± 0.301.23 ± 0.281.21 ± 0.311.21 ± 0.261.16 ± 0.311.23 ± 0.29
  n10610886846767
 Phase 1: Month 61.12 ± 0.26*1.21 ± 0.251.12 ± 0.241.20 ± 0.241.09 ± 0.271.21 ± 0.26
  n10310285*8166*63
 Phase 2: Month 91.14 ± 0.311.20 ± 0.271.14 ± 0.281.18 ± 0.271.12 ± 0.331.20 ± 0.27
  n626554*524239
 Phase 2: Month 121.14 ± 0.301.21 ± 0.261.14 ± 0.281.20 ± 0.251.09 ± 0.301.21 ± 0.27
  n10410286816663
Triglycerides (mmol/L)
 Baseline1.92 ± 1.362.10 ± 1.441.94 ± 1.422.21 ± 1.522.06 ± 1.582.05 ± 1.30
  n10610886846767
 Phase 1: Month 61.93 ± 1.232.04 ± 1.281.92 ± 1.052.10 ± 1.341.98 ± 1.312.07 ± 1.30
  n10310285816663
 Phase 2: Month 92.00 ± 1.212.23 ± 1.712.07 ± 1.262.29 ± 1.761.91 ± 0.982.36 ± 1.99
  n626554524239
 Phase 2: Month 121.90 ± 1.152.14 ± 1.491.91 ± 1.062.16 ± 1.541.90 ± 1.172.19 ± 1.49
  n10410286816663
Abdominal obesity and body composition
Body fat (%)
 Baseline33.60 ± 6.5432.24 ± 6.3333.99 ± 6.6932.37 ± 6.1733.58 ± 5.4332.54 ± 6.55
  n10811288886869
 Phase 1: Month 633.01 ± 6.8332.31 ± 5.7733.31 ± 6.8232.43 ± 5.5932.86 ± 5.9232.33 ± 5.88
  n949878786162
 Phase 2: Month 1232.81 ± 7.0832.63 ± 5.5733.08 ± 7.1832.66 ± 5.5132.69 ± 6.4432.68 ± 5.71
  n1009883786362
BMI (kg/m2)
 Baseline32.87 ± 6.5831.29 ± 5.4433.27 ± 6.8031.63 ± 5.0732.76 ± 6.1231.56 ± 5.87
   n10811288886869
 Phase 1: Month 633.07 ± 6.9631.45 ± 5.2633.28 ± 7.2831.67 ± 5.0333.16 ± 6.3531.70 ± 5.55
   n979980796262
 Phase 2: Month 1232.90 ± 7.0131.43 ± 5.2733.17 ± 7.3531.53 ± 5.0732.92 ± 6.5231.73 ± 5.57
   n1029984796462
Waist circumference (cm)
 Baseline112.7 ± 13.22110.1 ± 13.77113.3 ± 13.43110.8 ± 12.65112.7 ± 13.35111.7 ± 15.23
  n10811288886869
 Phase 1: Month 6111.9 ± 13.64110.2 ± 13.36112.0 ± 13.62110.3 ± 12.02113.1 ± 13.57111.8 ± 14.46
  n969980796162
 Phase 2: Month 12111.6 ± 13.89110.6 ± 13.96112.0 ± 13.92110.8 ± 12.52111.9 ± 13.79112.4 ± 15.52
  n10099837963*62
Blood pressure
Systolic blood pressure (mmHg)
 Baseline138.6 ± 17.30136.7 ± 17.12
  n108112
 Phase 2: Month 12138.7 ± 15.15134.9 ± 16.49
  n5058
Diastolic blood pressure (mmHg)
 Baseline82.5 ± 10.2381.6 ± 9.50
  n108112
Phase 2: Month 1282.8 ± 9.7280.3 ± 9.80
  n5058
Sexual dysfunction
IIEF total score
 Baseline32.4 ± 18.4732.8 ± 21.24
  n9498
 Phase 1: Month 641.3 ± 19.9739.3 ± 22.12
  n82*81
 Phase 2: Month 1240.9 ± 20.3437.3 ± 22.08
  n88*88
Erectile function domain score
 Baseline12.0 ± 9.0711.9 ± 10.02
  n101103
 Phase 1: Month 615.6 ± 9.5315.1 ± 10.49
  n8489
 Phase 2: Month 1215.2 ± 9.7114.4 ± 10.42
  n9093
Orgasmic function domain score
 Baseline4.6 ± 3.804.7 ± 4.20
  n105107
 Phase 1: Month 65.9 ± 3.895.8 ± 4.18
  n8890
 Phase 2: Month 125.5 ± 3.915.3 ± 4.23
  n9593
Sexual desire domain score
 Baseline5.3 ± 2.135.6 ± 2.47
  n105106
 Phase 1: Month 66.5 ± 2.275.9 ± 2.38
  n89**91
 Phase 2: Month 126.3 ± 2.215.8 ± 2.55
  n94**95
Intercourse satisfaction domain score
 Baseline4.7 ± 4.584.7 ± 4.84
  n106108
 Phase 1: Month 66.2 ± 4.956.3 ± 4.99
  n8891
 Phase 2: Month 126.4 ± 5.015.7 ± 4.89
  n94*92
Overall sexual satisfaction domain score
 Baseline4.7 ± 2.464.8 ± 2.68
  n9699
 Phase 1: Month 66.0 ± 2.625.7 ± 2.81
  n8589
 Phase 2: Month 125.9 ± 2.705.5 ± 2.73
  n9194
AMS total score
 Baseline40.6 ± 11.4439.9 ± 11.46
  n8896
 Phase 1: Month 637.1 ± 11.7236.1 ± 10.60
  n8086
 Phase 2: Month 1236.4 ± 11.1637.8 ± 11.57
  n8992
  • 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]).