Table 1.
Demographic and Clinical Characteristics of the Participants at Baseline.*
| Characteristic | Trial L1 | Trial L2 | ||||
|---|---|---|---|---|---|---|
| Placebo (N = 127) | Relugolix Combination Therapy (N = 128) | Delayed Relugolix Combination Therapy (N = 132) | Placebo (N = 129) | Relugolix Combination Therapy (N = 125) | Delayed Relugolix Combination Therapy (N = 127) | |
| Age — yr | 42.2±5.7 | 42.5±5.0 | 41.3±5.4 | 41.8±5.3 | 42.4±5.4 | 42.1±5.3 |
| Race or ethnic group — no. (%)† | ||||||
| White | 56 (44) | 64 (50) | 53 (40) | 49 (38) | 58 (46) | 50 (39) |
| Black | 65 (51) | 59 (46) | 67 (51) | 74 (57) | 62 (50) | 66 (52) |
| Other | 6 (5) | 5 (4) | 12 (9) | 5 (4) | 2 (2) | 8 (6) |
| Hispanic ethnic group† | 23 (18) | 34 (27) | 33 (25) | 32 (25) | 18 (14) | 34 (27) |
| Body-mass index‡ | 32.3±7.5 | 31.4±7.6 | 31.4±7.3 | 32.1±7.6 | 31.0±6.6 | 30.8±5.7 |
| Bone mineral density — g/cm2 | ||||||
| Lumbar spine§ | 1.23±0.17 | 1.16±0.17 | 1.21±0.19 | 1.24±0.16 | 1.22±0.17 | 1.22±0.18 |
| Total hip | 1.07±0.15 | 1.03±0.15 | 1.06±0.15 | 1.07±0.13 | 1.06±0.14 | 1.06±0.15 |
| Menstrual blood loss | ||||||
| Volume — ml | 218.8±125.0 | 239.4±180.3 | 228.9±159.6 | 211.8±129.9 | 246.7±186.0 | 227.4±134.4 |
| Distribution — no. (%) | ||||||
| <225 ml | 85 (67) | 84 (66) | 86 (65) | 86 (67) | 80 (64) | 80 (63) |
| ≥225 ml | 42 (33) | 44 (34) | 46 (35) | 43 (33) | 45 (36) | 47 (37) |
| Hemoglobin concentration — g/dl | 11.4±1.4 | 11.2±1.6 | 11.1±1.7 | 11.1±1.6 | 11.3±1.5 | 11.1±1.6 |
| Uterine-fibroid volume — cm3 | 71.8±124.0 | 71.9±128.1 | 93.8±143.8 | 74.1±123.0 | 73.7±126.7 | 78.9±157.5 |
| Uterine volume — cm3 | 397.8±324.9 | 379.1±316.8 | 469.9±427.9 | 407.9±402.0 | 387.7±344.0 | 402.7±371.1 |
| Bleeding and Pelvic Discomfort scale score¶ | 71.4±21.3 | 66.8±22.1 | 68.5±22.9 | 70.0±20.3 | 70.7±20.8 | 72.0±22.9 |
| Maximum numerical rating scale score for uterine fibroid–associated pain ≥4 — no. (%)‖ | 95 (75) | 84 (66) | 89 (67) | 95 (74) | 93 (74) | 92 (72) |
Plus–minus values are means ±SD. L1 denotes LIBERTY 1, and L2 LIBERTY 2.
Race and ethnic group were reported by the participant. Other race or ethnic group included Asian, American Indian or Alaska Native, other race or ethnic group, and multiple races or ethnic groups. Percentages may not total 100 because of rounding or because of missing data: in trial L2, race or ethnic group was not reported by 1 participant in the placebo group, by 3 in the relugolix combination therapy group, and by 3 in the delayed relugolix combination therapy group. In trial L1, Hispanic ethnic group was not reported by 1 participant in the placebo group and by 2 in the delayed relugolix combination therapy group; in trial L2, Hispanic ethnic group was not reported by 1 participant in the placebo group, by 2 in the relugolix combination therapy group, and by 2 in the delayed relugolix combination therapy group.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
Bone mineral density at the lumbar spine was assessed in the area from L1 through L4.
The Bleeding and Pelvic Discomfort scale score is calculated as the sum of scores for three symptoms (heavy bleeding during menstrual period, passing blood clots during menstrual period, and feeling tightness or pressure in pelvic area), each of which is scored on a scale from 1 to 5, with higher scores indicating greater symptom severity. Raw scores range from 3 to 15 and are normalized by dividing the difference between the reported score and the lowest possible raw score (i.e., 3) by the raw score range (i.e., 12) and then multiplying by 100.
Numerical rating scale scores for pain attributed to uterine fibroids range from 0 (no pain) to 10 (worst imaginable pain). Scores were recorded in a daily electronic diary. The numerical rating scale score at baseline was defined as the maximum score from the 35 days of data collected before the date of the first dose of relugolix or placebo. In the placebo groups and relugolix combination therapy groups, the baseline numerical rating scale scores were missing for 1 participant and 1 participant, respectively, in trial L1 and for 3 and 2 participants, respectively, in trial L2. No participants in the delayed relugolix therapy group in either trial had missing scores.