Table 1 Demographics and baseline characteristics
From: Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial
Variables | Relugolix | Placebo | ||
|---|---|---|---|---|
10 mg (n = 48) | 20 mg (n = 56) | 40 mg (n = 55) | (n = 57) | |
Age (years), mean ± SD | 42.7 ± 4.6 | 42.6 ± 5.3 | 41.1 ± 4.4 | 42.4 ± 5.1 |
BMI (kg/m2), mean ± SD | 22.9 ± 2.7 | 21.9 ± 2.8 | 22.4 ± 2.8 | 23.8 ± 4.2 |
Parity ≥ 1, n (%) | 25 (52.1) | 29 (51.8) | 20 (36.4) | 30 (52.6) |
Type of uterine leiomyoma, n (%) | ||||
Subserosal | 22 (45.8) | 25 (44.6) | 17 (30.9) | 23 (40.4) |
Intramural | 39 (81.3) | 44 (78.6) | 45 (81.8) | 42 (73.7) |
Submucosal | 11 (22.9) | 11 (19.6) | 11 (20.0) | 12 (21.1) |
Cervical | 1 (2.1) | 1 (1.8) | 2 (3.6) | 1 (1.8) |
Volume of myoma (cm3) | ||||
Mean ± SD | 115.6 ± 127.4 | 118.7 ± 117.4 | 138.0 ± 199.8 | 136.1 ± 159.1 |
Median (Q1, Q3) | 61.6 (30.7, 170.9) | 72.1 (27.1, 173.6) | 68.2 (27.2, 167.0) | 82.0 (43.6, 141.3) |
Volume of uterus (cm3) | ||||
Mean ± SD | 322.1 ± 285.0 | 363.3 ± 304.6 | 406.6 ± 361.8 | 366.5 ± 276.6 |
Median (Q1, Q3) | 212.0 (161.1, 383.8) | 271.7 (172.7, 427.5) | 291.0 (145.0, 557.6) | 263.0 (157.0, 482.6) |
PBAC score | ||||
Mean ± SD | 269.4 ± 160.8 | 276.5 ± 165.9 | 259.9 ± 190.5 | 327.9 ± 292.1 |
Median (Q1, Q3) | 211.0 (139.0, 364.5) | 214.0 (155.0, 331.0) | 219.0 (159.0, 302.0) | 232.0 (165.0, 351.0) |
Pain NRS scorea, mean ± SD | 0.7 ± 1.1 | 0.8 ± 0.9 | 0.6 ± 0.6 | 0.8 ± 0.8 |
UFS-QOL scoreb, mean ± SD | ||||
Symptom severity | 29.3 ± 17.3 | 25.8 ± 14.4 | 25.3 ± 14.0 | 27.6 ± 17.7 |
HRQL total | 85.7 ± 11.9 | 87.2 ± 11.5 | 85.0 ± 15.5 | 83.9 ± 18.8 |
Hemoglobin (g/dL), mean ± SD | 12.2 ± 1.2 | 12.2 ± 1.4 | 12.0 ± 1.7 | 12.1 ± 1.5 |