Table 1.
Demographics and baseline characteristics
| 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 |
BMI body mass index, HRQL health-related quality of life, NRS numerical rating scale, PBAC pictorial blood loss assessment chart, UFS-QOL uterine fibroid symptom and quality of life
aNRS is a patient-reported pain assessment with an 11-point scale ranging from 0 to 10. Higher NRS scores indicate worse pain
bUFS-QOL is a patient-reported tool to assess quality of life in patients with uterine leiomyomas. The score ranges from 0 to 100. Higher symptom severity scores indicate more severe symptoms, but higher HRQL scores indicate better HRQL