Table 1.
Baseline characteristics of study participants by treatment arm and overall
| Placebo N = 36 | 1 mg/day N = 28 | 5 mg/day N = 36 | 15 mg/day N = 14 | Overall N = 114 | |
|---|---|---|---|---|---|
| Age, years | 67.1 ± 6.1 | 67.1 ± 7.87 | 67.4 ± 8.6 | 69.6 ± 7.1 | 67.5 ± 7.5 |
| Weight, kg | 84.9 ± 12.7 | 92.7 ± 10.7 | 89.7 ± 15.4 | 86.7 ± 12.5 | 88.5 ± 13.4 |
| BMI, kg/m 2 | 27.9 ± 3.8 | 29.8 ± 3.89 | 29.3 ± 4.1 | 29.2 ± 5.1 | 29.0 ± 4.1 |
| SPPB score | 11.4 ± 1.15 | 11.1 ± 1.21 | 11.1 ± 1.42 | 11.1 ± 1.07 | 11.2 ± 1.24 |
| PDQ-4 | |||||
| Sexual Activity score | 1.55 ± 1.20 | 1.38 ± 1.28 | 1.76 ± 1.54 | 0.97 ± 1.20 | 1.50 ± 1.32 |
| Mood | |||||
| Positive | 5.22 ± 1.12 | 5.53 ± 0.86 | 5.44 ± 1.11 | 5.17 ± 0.93 | 5.36 ± 1.03 |
| Negative | 1.12 ± 0.86 | 1.38 ± 1.14 | 1.09 ± 0.95 | 1.58 ± 0.92 | 1.23 ± 0.97 |
| IIEF | 22.4 ± 16.9 | 21.0 ± 14.7 | 22.9 ± 16.0 | 22.2 ± 17.3 | 22.2 ± 15.9 |
| Erectile Function | 7.2 ± 8.6 | 6.5 ± 6.9 | 8.0 ± 7.8 | 7.2 ± 8.9 | 7.3 ± 7.9 |
| Intercourse Satisfaction | 2.4 ± 4.2 | 1.8 ± 3.6 | 2.6 ± 3.9 | 2.5 ± 4.5 | 2.3 ± 4.0 |
| Orgasmic Function | 4.2 ± 3.3 | 4.0 ± 3.7 | 4.0 ± 3.6 | 3.8 ± 4.0 | 4.1 ± 3.5 |
| Sexual Desire | 4.4 ± 1.7 | 4.6 ± 2.0 | 4.8 ± 1.9 | 4.6 ± 1.6 | 4.6 ± 1.8 |
| Overall Satisfaction | 4.3 ± 2.1 | 4.1 ± 1.9 | 3.6 ± 1.9 | 4.6 ± 1.8 | 4.1 ± 1.9 |
| IPSS | |||||
| Symptom | 7.1 ± 5.1 | 7.8 ± 6.0 | 5.6 ± 3.9 | 6.9 ± 3.2 | 6.7 ± 4.8 |
| Quality of Life Due to Urinary Symptoms | 2.0 ± 1.4 | 1.8 ± 1.1 | 1.7 ± 1.5 | 2.0 ± 1.5 | 1.8 ± 1.4 |
| DISF-M-II | 48.1 ± 20.5 | 42.4 ± 19.1 | 39.9 ± 17.3 | 40.8 ± 20.8 | 43.2 ± 19.3 |
| Sexual Desire | 14.6 ± 3.97 | 14.4 ± 6.22 | 14.9 ± 4.43 | 14.3 ± 5.44 | 14.6 ± 4.87 |
| Sexual Arousal | 5.06 ± 6.18 | 4.21 ± 5.31 | 4.58 ± 4.64 | 4.86 ± 5.63 | 4.68 ± 5.39 |
| Sexual Activity | 8.78 ± 4.11 | 7.18 ± 3.83 | 6.64 ± 4.11 | 6.43 ± 3.39 | 7.42 ± 4.03 |
| Orgasm | 8.58 ± 5.75 | 8.00 ± 6.45 | 6.97 ± 5.26 | 8.50 ± 6.37 | 7.92 ± 5.82 |
| Sexual Satisfaction | 11.0 ± 6.9 | 8.61 ± 5.00 | 6.75 ± 5.43 | 6.71 ± 4.58 | 8.55 ± 5.97 |
| MSHQ | |||||
| Erection | 5.32 ± 3.10 | 4.84 ± 2.90 | 5.92 ± 3.47 | 5.92 ± 4.23 | 5.48 ± 3.30 |
| Ejaculation | 7.12 ± 6.94 | 7.92 ± 6.14 | 8.61 ± 8.04 | 8.67 ± 8.75 | 7.98 ± 7.31 |
| Satisfaction | 19.1 ± 4.84 | 17.1 ± 3.82 | 15.7 ± 5.68 | 15.4 ± 3.70 | 17.1 ± 4.99 |
| FACIT-F | 41.9 ± 8.82 | 42.1 ± 8.07 | 43.2 ± 7.55 | 42.4 ± 6.42 | 42.4 ± 7.89 |
| PANAS | |||||
| Positive Affect | 33.4 ± 7.07 | 34.5 ± 5.21 | 34.8 ± 6.38 | 34.1 ± 7.62 | 34.2 ± 6.46 |
| Negative Affect | 14.9 ± 6.08 | 13.7 ± 2.97 | 14.0 ± 4.71 | 17.2 ± 6.56 | 14.6 ± 5.15 |
| Physical function | |||||
| Gait speed in 6-minute walk, m/sec | 1.54 ± 0.20 | 1.54 ± 0.14 | 1.45 ± 0.22 | 1.44 ± 0.21 | 1.50 ± 0.20 |
| Unloaded 50m walk gait speed, m/sec | 2.01 ± 0.30 | 2.05 ± 0.27 | 2.04 ± 0.39 | 1.74 ± 0.29 | 1.99 ± 0.33 |
| Loaded 50m walk gait speed, m/sec | 1.97 ± 0.27 | 1.98 ± 0.26 | 1.94 ± 0.37 | 1.75 ± 0.31 | 1.93 ± 0.31 |
| Unloaded stair climb power, watts | 464.0 ± 116.3 | 525.6 ± 103.0 | 471.0 ± 133.9 | 442.6 ± 122.3 | 476.5 ± 121.3 |
| Loaded stair climb power, watts | 523.8 ± 122.3 | 600.3 ± 119.4 | 557.0 ± 176.6 | 544.8 ± 100.9 | 552.2 ± 134.8 |
| Leg Press 1-RM, N | 2333.6 ± 470.9 | 2294.0 ± 441.5 | 2407.3 ± 420.8 | 2347.2 ± 384.8 | 2351.4 ± 430.8 |
| Physical function domain of MOS SF-36 score | 88.4 ± 12.4 | 87.8 ± 15.2 | 84.4 ± 17.3 | 85.4 ± 24.1 | 86.6 ± 16.3 |
| DXA | |||||
| Appendicular fat mass, kg | 10.9 ± 2.8 | 13.2 ± 3.5 | 11.8 ± 3.7 | 10.9 ± 3.2 | 11.7 ± 3.4 |
| Trunk Fat Mass, kg | 15.7 ± 4.4 | 18.5 ± 5.1 | 16.5 ± 4.8 | 16.5 ± 5.8 | 16.7 ± 4.9 |
| Total fat mass, kg | 27.8 ± 6.9 | 33.0 ± 8.3 | 29.5 ± 8.2 | 28.6 ± 9.1 | 29.7 ± 8.1 |
| Appendicular lean mass, kg | 23.7 ± 3.2 | 24.7 ± 2.4 | 24.1 ± 3.8 | 23.7 ± 3.6 | 24.0 ± 3.3 |
| Trunk lean mass, kg | 26.9 ± 3.8 | 27.1 ± 5.7 | 27.4 ± 4.0 | 26.9 ± 3.4 | 27.1 ± 4.3 |
| Total Lean Mass, kg | 54.0 ± 6.9 | 56.3 ± 5.0 | 55.0 ± 7.9 | 54.1 ± 6.9 | 54.9 ± 6.8 |
| Total percent fat, % | 32.6 ± 5.08 | 35.4 ± 6.03 | 33.3 ± 4.34 | 32.9 ± 6.50 | 33.5 ± 5.33 |
| Laboratory hematology | |||||
| White blood cell count, K/uL | 6.20 ± 1.46 | 5.66 ± 1.65 | 5.98 ± 1.48 | 5.87 ± 1.52 | 5.96 ± 1.52 |
| Red blood cell count, Mcells/uL | 4.89 ± 0.34 | 4.81 ± 0.38 | 4.85 ± 0.47 | 4.85 ± 0.56 | 4.85 ± 0.42 |
| Hemoglobin, g/dL | 14.9 ± 1.23 | 15.0 ± 0.84 | 14.9 ± 0.95 | 14.7 ± 1.04 | 14.9 ± 1.02 |
| Hematocrit, % | 44.6 ± 3.19 | 45.1 ± 2.71 | 44.7 ± 3.04 | 44.0 ± 3.34 | 44.7 ± 3.03 |
| MCV, fL | 91.3 ± 3.39 | 94.0 ± 5.05 | 92.5 ± 4.69 | 91.3 ± 6.91 | 92.3 ± 4.81 |
| MCH, pg | 30.4 ± 1.47 | 31.2 ± 1.76 | 30.9 ± 1.91 | 30.4 ± 2.08 | 30.8 ± 1.77 |
| MCHC, g/dL | 33.3 ± 0.86 | 33.2 ± 0.64 | 33.4 ± 0.76 | 33.4 ± 0.89 | 33.3 ± 0.77 |
| RDW, % | 13.9 ± 1.16 | 14.0 ± 0.72 | 14.0 ± 1.20 | 13.6 ± 1.14 | 13.9 ± 1.07 |
| Platelet count, K/uL | 213.8 ± 43.4 | 198.4 ± 45.8 | 213.7 ± 58.7 | 205.6 ± 41.3 | 209.0 ± 48.9 |
| MPV, fL | 9.58 ± 0.99 | 9.21 ± 0.97 | 9.36 ± 1.03 | 9.97 ± 1.43 | 9.47 ± 1.07 |
| PSA, ng/mL | <0.1 | <0.1 | <0.1 | <0.1 | <0.1 |
| Glucose homeostasis | |||||
| Hemoglobin A1c, % | 5.80 ± 0.45 | 5.68 ± 0.45 | 5.63 ± 0.48 | 5.61 ± 0.53 | 5.69 ± 0.47 |
| Glucose, mg/dL | 104.0 ± 17.5 | 99.4 ± 14.0 | 97.3 ± 10.0 | 103.2 ± 20.8 | 100.6 ± 15.2 |
| Insulin, uIU/mL | 8.33 ± 4.83 | 10.5 ± 5.21 | 10.0 ± 5.65 | 9.06 ± 5.02 | 9.49 ± 5.23 |
| HOMA-IR | 2.15 ± 1.52 | 2.74 ± 1.46 | 2.45 ± 1.44 | 2.32 ± 1.23 | 2.40 ± 1.44 |
| Liver function tests | |||||
| AST, U/L | 21.4 ± 6.76 | 23.3 ± 5.80 | 19.7 ± 3.83 | 25.1 ± 7.87 | 21.7 ± 6.10 |
| ALT, U/L | 22.3 ± 7.63 | 28.4 ± 17.2 | 21.4 ± 7.47 | 25.5 ± 10.9 | 23.9 ± 11.3 |
| Total bilirubin, mg/dL | 0.69 ± 0.23 | 0.73 ± 0.26 | 0.77 ± 0.39 | 0.65 ± 0.22 | 0.72 ± 0.30 |
| Lipid panel | |||||
| Total cholesterol, mg/dL | 178.4 ± 28.0 | 174.9 ± 29.6 | 173.4 ± 33.1 | 179.3 ± 30.6 | 176.1 ± 30.1 |
| HDL-cholesterol, mg/dL | 56.1 ± 14.6 | 51.5 ± 13.9 | 51.3 ± 13.2 | 50.7 ± 15.4 | 52.8 ± 14.1 |
| LDL-cholesterol, mg/dL | 102.4 ± 25.1 | 100.8 ± 28.1 | 100.7 ± 28.8 | 103.7 ± 24.2 | 101.6 ± 26.6 |
| Triglycerides, mg/dL | 99.2 ± 41.3 | 122.0 ± 56.8 | 107.9 ± 46.2 | 142.1 ± 90.2 | 112.8 ± 55.6 |
| Bone markers | |||||
| NTx, nM BCE | 13.8 ± 6.25 | 13.2 ± 4.81 | 12.2 ± 4.41 | 11.3 ± 5.59 | 12.8 ± 5.28 |
| Osteocalcin, ng/mL | 9.33 ± 4.47 | 9.24 ± 4.42 | 9.37 ± 4.51 | 6.89 ± 2.27 | 9.02 ± 4.28 |
| PINP, ug/L | 53.1 ± 23.8 | 51.0 ± 16.2 | 45.2 ± 14.4 | 42.2 ± 14.0 | 48.6 ± 18.4 |
| Alkaline phosphatase, U/L | 73.0 ± 16.9 | 62.3 ± 16.3 | 59.3 ± 15.9 | 63.3 ± 11.5 | 64.9 ± 16.7 |
| Bone alkaline phosphatase, ng/mL | 18.5 ± 7.18 | 15.4 ± 4.90 | 15.9 ± 4.73 | 14.5 ± 3.01 | 16.4 ± 5.62 |
| Testosterone | |||||
| Total testosterone, ng/dL | 391.1 ± 120.7 | 379.7 ± 140.9 | 398.5 ± 192.6 | 392.1 ± 102.7 | 391.0 ± 149.4 |
| Free testosterone, pg/mL | 28.2 ± 9.4 | 31.0 ± 12.8 | 30.2 ± 9.7 | 30.0 ± 9.0 | 29.7 ± 10.2 |
| SHBG, nmol/L | 36.2 ± 14.1 | 36.5 ± 14.1 | 39.1 ± 16.1 | 38.5 ± 17.7 | 37.5 ± 15.1 |
| LH, mIU/mL | 5.68 ± 5.24 | 4.50 ± 2.89 | 6.03 ± 6.10 | 4.04 ± 2.46 | 5.34 ± 4.89 |
| Estradiol, pg/mL | 24.8 ± 8.4 | 25.4 ± 8.1 | 27.0 ± 7.9 | 27.4 ± 5.3 | 26.0 ± 7.8 |
Values are presented as mean ± SD.
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; BMI, body mass index; DISF-M-II, DeRogatis Inventory of Sexual Function for Men—II; DXA, dual-energy X-ray absorptiometry; FACIT-F, Functional Assessment of Chronic Illness Therapy—Fatigue; HDL, high-density lipoprotein; HOMA-IR, homeostatic model assessment for insulin resistance; IIEF, International Index of Erectile Function; IPSS, International Prostate Symptom Scale; LDL, low-density lipoprotein; LH, luteinizing hormone; MCV, mean corpuscular volume; MSHQ, Male Sexual Health Questionnaire; NTx, N-telopeptide of type I collagen; PANAS, Positive and Negative Affect Scale; PDQ-4, Psychosexual Daily Questionnaire, Question 4; PINP, procollagen I intact N-terminal; RDW, red blood cell distribution width; SHBG, sex hormone–binding globulin; SPPB, Short Physical Performance Battery.