Table 1.
Baseline Demographics and Characteristics
| Characteristic | Responders |
Nonresponders |
||
|---|---|---|---|---|
| Placebo | Elagolix+add-back therapy | Placebo | Elagolix+add-back therapy | |
| Age (y) |
n = 16 42.0 ± 5.0 |
n = 278 42.4 ± 5.2 |
n = 166 41.9 ± 5.7 |
n = 89 42.8 ± 5.4 |
| Race | n = 16 | n = 278 | n = 166 | n = 89 |
| Black or African American | 11 (68.8) | 187 (67.5) | 115 (69.3) | 62 (69.7) |
| Not black or African American | 5 (31.3) | 90 (32.5) | 51 (30.7) | 27 (30.3) |
| Body mass index (kg/m2) |
n = 16 31.7 ± 6.4 |
n = 277 33.6 ± 6.9 |
n = 166 34.3 ± 7.6 |
n = 89 33.2 ± 7.2 |
| Menstrual blood loss/cycle (mL) |
n = 16 198.5 ± 93.5 |
n = 278 217.9 ± 134.7 |
n = 166 262.8 ± 180.4 |
n = 89 270.3 ± 173.2 |
| Hemoglobin level (g/dL) |
n = 16 11.8 ± 1.3 |
n = 278 11.2 ± 1.5 |
n = 166 10.9 ± 1.4 |
n = 89 11.1 ± 1.6 |
| Uterine volume (cm3) | ||||
| Measured with TAU or TVU |
n = 16 324.6 ± 203.7 |
n = 278 479.0 ± 369.2 |
n = 166 539.3 ± 425.2 |
n = 89 518.8 ± 439.7 |
| Measured with MRI |
n = 11 420.6 ± 241.2 |
n = 140 566.5 ± 430.4 |
n = 82 722.5 ± 653.3 |
n = 37 662.5 ± 572.0 |
| Average fibroid volume (cm3) | ||||
| Measured with TAU or TVU |
n = 16 30.7 ± 38.8 |
n = 272 51.9 ± 75.5 |
n = 162 65.9 ± 91.5 |
n = 89 64.5 ± 122.8 |
| Measured with MRI |
n = 11 36.2 ± 39.2 |
n = 132 69.5 ± 71.9 |
n = 76 93.9 ± 113.4 |
n = 35 65.7 ± 60.5 |
Data are mean ± SD or n (%). Add-back therapy defined as estradiol 1 mg/norethindrone acetate 0.5 mg once daily.
SD, standard deviation; TAU, transabdominal ultrasonography; TVU, transvaginal ultrasonography; MRI, magnetic resonance imaging.