Table 1.
Baseline Characteristics
| 300 mg Elagolix Twice Daily |
600 mg Elagolix Daily |
|||||||
|---|---|---|---|---|---|---|---|---|
| Characteristic | Placebo (n=65) | Without Add-Back (n=65) | +0.5 mg E2/0.1 mg NETA (n=64) | +1.0 mg E2/0.5 mg NETA (n=65) | Placebo (n=78) | Without Add-Back (n=77) | +0.5 mg E2/0.1 mg NETA (n=76) | +1.0 mg E2/0.5 mg NETA (n=77) |
| Age (y) | 44 (29–50) | 43 (29–50) | 44 (26–52) | 44 (29–51) | 43 (27–51) | 42 (25–51) | 42 (30–52) | 43 (25–51) |
| Race | ||||||||
| Black | 44 (68) | 41 (63) | 46 (72) | 50 (77) | 61 (78) | 51 (66) | 60 (79) | 55 (72) |
| White | 18 (28) | 21 (32) | 18 (28) | 14 (22) | 17 (22) | 22 (29) | 13 (17) | 18 (24) |
| Other† | 3 (4.6) | 3 (4.6) | 0 | 1 (1.5) | 0 | 4 (5.2) | 3 (3.9) | 3 (3.9) |
| BMI (kg/m2) | 30±4.7 | 30±5.4 | 30±5.6 | 30±5.1 | 30.7±5.1 | 30±5.2 | 31±5.5 | 31±5.7 |
| Menstrual blood loss (mL) | 238±189 | 265±146 | 270±220 | 296±253 | 222±132 | 208±141 | 242±157 | 247±187 |
| Hemoglobin (g/dL) | 11.1±1.6 | 10.5±1.5* | 11.0±1.7 | 10.4±1.7* | 10.9±1.6 | 10.7±1.9 | 10.6±1.9 | 11.0±1.8 |
| Total uterine volume (cm3) | 627±440 | 680±471 | 634±456 | 816±596* | 570±381 | 577±444 | 579±436 | 582±441 |
| Total leiomyoma volume (cm3)‡ | 135±155 | 175±211 | 150±176 | 188±209 | 138±161 | 132±156 | 147±267 | 149±209 |
| UFS-QoL symptom severity score (LS mean±SE) | 62.1±2.5 | 63.1±2.5 | 59.8±2.5 | 64.8±2.5 | 65.9±2.4 | 66.3±2.4 | 63.2±2.4 | 62.1±2.4 |
| UFS-QoL HRQL total (LS mean±SE) | 39.4±3.1 | 39.9±3.1 | 43.3±3.1 | 35.9±3.1 | 37.2±2.6 | 34.3±2.6 | 37.4±2.7 | 37.5±2.6 |
| Bone mineral density Z-score, lumbar spine | 0.72±1.25 | 0.73±1.16 | 0.86±1.05 | 0.80±1.20 | 1.09±1.21 | 0.87±1.18 | 0.53±1.07 | 1.16±1.22 |
| Total hip | 0.56±0.98 | 0.32±0.73 | 0.57±0.91 | 0.28±1.08 | 0.52±0.95 | 0.40±0.96 | 0.61±1.06 | 0.62±0.97 |
| Femoral neck | 0.47±0.97 | 0.27±0.74 | 0.30±0.94 | 0.32±1.16 | 0.44±1.01 | 0.37±0.99 | 0.46±0.90 | 0.50±1.04 |
E2, estradiol; NETA, norethindrone acetate; BMI, body mass index; UFS-QOL, Fibroid Symptom and Health Related Quality of Life; LS, least square; SE, standard error; HRQL, Health Related Quality of Life.
Data are median (range), n (%), or mean±SD unless otherwise specified. Significant differences between each elagolix group and placebo for menstrual blood loss, hemoglobin concentration, total uterine, and leiomyoma volumes at baseline were tested using an analysis of variance model with treatment as the main effect and indicated for
*
P<.05.
†
Other category includes Asian, Native American and Alaska Native, Native Hawaiian or other Pacific islander, and multiracial.
‡
Volume of three or less largest leiomyomas.