Table 2.

Baseline Clinical Characteristics & Treatment Effects

	Placebo (n = 12)			Testosterone ( n = 13)			Baseline Comparison	Change Between Groups
Variable	Baseline	Change at 9M	Change at 18M	Baseline	Change at 9M	Change at 18M	P Value	P Value
Body Composition
Body Mass Index (kg/m²)	23.2 ± 0.7	−0.1 ± 0.4	0.8 ± 0.6	22.4 ± 1.0	1.2 ± 0.4	1.6 ± 0.4	0.53	0.03
Weight (kg)	59.9 ± 1.7	−0.1 ± 1.0	2.0 ± 1.7	59.7 ± 3.2	3.0 ± 1.0	4.2 ± 1.2	0.95	0.03
Total Lean Mass (kg)	42.1 ± 0.9	−0.3 ± 0.5	0.8 ± 0.9	44.1 ± 2.1	1.2 ± 0.4	1.8 ± 0.5	0.42	0.04
Total Fat Mass (kg)	17.7 ± 1.6	0.0 ± 0.7	0.6 ± 1.0	15.7± 1.3	1.6 ± 1.0	1.7 ± 1.0	0.36	0.16
Metabolic Parameters
Cholesterol (mg/dL)[mmol/L]	180 ± 12 [4.66 ± 0.31]	8 ± 6 [0.21 ± 0.16]	−5 ± 10 [−0.13 ± 0.26]	196 ± 17 [5.08 ± 0.44]	−11 ± 12 [−0.28 ± 0.31]	2 ± 9 [0.05 ± 0.23]	0.49	0.66
Low Density Lipoprotein (mg/dl)[mmol/L]	114 ± 11 [2.95 ± 0.28]	2 ± 6 [0.05 ± 0.16]	−10 ± 10 [−0.26 ± 0.26]	123 ± 14 [3.19 ± 0.36]	−10 ± 9 [−0.26 0.23]	−3 ± 7 [−0.08 ± 0.18]	0.60	0.79
High Density Lipoprotein (mg/dl)[mmol/L]	47 ± 3 [1.22 ± 0.08]	2 ± 2 [0.05 ± 0.05]	−1 ± 3 [−0.03 ± 0.08]	46 ± 3 [1.19 ± 0.08]	−2 ± 3 [−0.05 ± 0.08]	−6 ± 2 [−0.16 ± 0.05]	0.90	0.18
Triglycerides (mg/dl)[mmol/L]	100 ± 16 [1.13 ± 0.18]	22 ± 16 [0.25 ± 0.18]	30 ± 16 [0.34 ± 0.18]	132 ± 19 [1.49 ± 0.21]	11 ± 17 [0.12 ± 0.19]	105 ± 75 [1.19 ± 0.85]	0.21	0.56
0 minute Glucose (mg/dL)[mmol/L]	86 ± 2 [4.77 ± 0.11]	7 ± 3 [0.39 ± 0.17]	8 ± 5 [0.44 ± 0.28]	93 ± 6 [5.16 ± 0.33]	−7 ± 5 −0.39 ± 0.28	−4 ± 7 −0.22 ± 0.39	0.25	0.03
120 minute Glucose (mg/dL)[mmol/L]	131 ± 18 [7.27 ± 1.00]	6 ± 8 [0.33 ± 0.44]	14 ± 9 [0.78 ± 0.50]	114 ± 8 [6.33 ± 0.44]	[−4 ± 8] [−0.22 ± 0.44]	[18 ± 12] [1.00 ± 0.67]	0.37	0.85
0 minute Insulin (mcg IU/mL)[pmol/L]	4.8 ± 0.7 [33 ± 5]	2.8 ± 1.2 [19 ± 8]	−79.3 ± 2.4 [−551 ± 17]	7.0 ± 1.4 [49 ± 10]	−0.5 ± 0.6 [−3 ± 4]	−86.1 ± 6.7 [−598 ± 47]	0.23	0.21
Serum glutamic pyruvic transaminase (U/L)	24 ± 3	0 ± 4	−4 ± 4	27 ± 7	5 ± 2	−3 ± 5	0.67	0.52
Caloric Intake (kcal/d)	2148 ± 174	−85 ± 185	466 ± 544	2088 ± 231	−132 ± 218	−194 ± 226	0.84	0.27
Hormones
Free Testosterone (pg/ml)[pmol/L]	1.4 ± 0.2 [5 ± 1]	0.0 ± 0.3 [0 ± 1]	0.3 ± 0.4 [1 ± 1]	1.2 ± 0.1 [4 ± 0]	5.1 ± 1.5 [18 ± 5]	7.9 ± 1.8 [27 ± 6]	0.45	0.002
Total Testosterone (ng/dl)[nmol/L]	20 ± 2 [0.7 ± 0.1]	3 ± 3 [0.1 ± 0.1]	2 ± 4 [0.1 ± 0.1]	21 ± 5 [0.7 ± 0.2]	66 ± 19 [2.3 ± 0.7]	104 ± 24 [3.6 ± 0.8]	0.88	0.001
Lutenizing Hormone (mIU/L)[IU/L]	18 ± 6	−7 ± 5	−5 ± 8	20 ± 6	−7 ± 3	−6 ± 4	0.81	0.95
Follicular Stimulating Hormone (mIU/mL)[IU/L]	20 ± 7	−2 ± 2	−2 ± 5	23 ± 7	−3 ± 3	−1 ± 3	0.75	0.90
Estradiol (pg/ml)[pmol/L]	57 ± 11 [209 ± 40]	−2 ± 18 [−7 ± 66]	−7 ± 17 [−26 ± 62]	64 ± 14 [235 ± 51]	−15 ± 8 [−55 ± 29]	−13 ± 15 [−48 ± 55]	0.72	0.52
SHBG (nmol/L)[nmol/L]	144 ± 9	17 ± 8	1 ± 12	139 ± 24	−6 ± 11	−5 ± 12	0.87	0.18
Bone Mineral Density
Lumbar BMD (g/cm²)	1.03 ± 0.03	−0.01 ± 0.01	−0.02 ± 0.01	0.98 ± 0.03	0.01 ± 0.01	−0.02 ± 0.01	0.33	0.45
Hip BMD (g/cm²)	0.93 ± 0.03	−0.02 ± 0.01	−0.01 ± 0.01	0.86 ± 0.04	0.01 ± 0.00	0.01 ± 0.01	0.13	0.02
Trochanter BMD (g/cm²)	0.70 ± 0.03	−0.02 ± 0.01	−0.02 ± 0.01	0.62 ± 0.03	0.02 ± 0.01	0.01± 0.01	0.08	0.01
Quality of Life
Becks Depression Inventory	11.8 ± 2.8	0.3 ± 2.4	−1.9 ± 3.1	11.7 ± 2.8	−2.7 ± 1.6	−6.8 ± 2.2	0.98	0.02
Brief Index of Sexual Function:
D1: Thoughts/ Desires	2.7 ± 0.6	0.5 ± 0.7	−0.4 ± 0.6	3.9 ± 1.2	0.3 ± 1.1	1.4 ± 0.8	0.32	0.75
D2: Arousal	1.1 ± 0.5	0.9 ± 0.5	0.3 ± 0.5	2.7 ± 1.0	0.2 ± 1.2	0.8 ± 1.7	0.16	0.88
D3: Frequency of Sexual Activity	0.9 ± 0.3	0.6 ± 0.8	−0.6 ± 0.2	1.9 ± 0.8	0.3 ± 0.7	0.0 ± 0.8	0.25	0.64
D4: Receptivity/ Initiation	3.2 ± 1.4	−0.1 ± 0.6	−0.3 ± 0.8	4.4 ± 1.4	−0.9 ± 1.5	3.7 ± 2.1	0.57	0.62
D5: Pleasure/ Orgasm	1.9 ± 0.9	−0.3 ± 0.9	−0.9 ± 0.7	2.0 ± 0.9	0.5 ± 1.1	0.5 ± 1.1	0.91	0.26
D6: Relationship Satisfaction	5.0 ± 1.1	−1.6 ± 1.0	−1.8 ± 1.1	6.8 ± 1.2	−1.1 ± 1.3	−0.4 ± 1.9	0.28	0.59
D7: Problems Affecting Sexual Function	3.4 ± 0.7	0.4 ± 0.4	0.5 ± 0.5	4.4 ± 0.7	−1.6 ± 0.6	−1.8 ± 0.8	0.39	0.01