Table 1.
Baseline characteristics.
| Characteristic | Placebo | Linzagolix 75 mg | Linzagolix 200 mg + ABT |
|---|---|---|---|
| (N = 162) | (N = 160) | (N = 162) | |
| Age (years), mean (SD) | 34.9 (6.8) | 35.1 (6.4) | 34.6 (6.8) |
| Race | |||
| White, n (%) | 160 (98.8) | 158 (98.8) | 159 (98.1) |
| Black or African-American, n (%) | 2 (1.2) | 1 (0.6) | 1 (0.6) |
| Asian, n (%) | 0 | 1 (0.6) | 0 |
| Other, n (%) | 0 | 0 | 0 |
| BMI (kg/m2), mean (SD) | 24.14 (4.44) | 24.60 (5.23) | 24.09 (5.17) |
| Time since first seeking medical diagnosis/treatment (years), mean (SD) | 4.94 (4.51) | 5.15 (4.38) | 5.50 (4.74) |
| Pain scores | |||
| Baseline overall pelvic pain VRS*, mean (SD) | 1.90 (0.40) | 1.87 (0.41) | 1.92 (0.42) |
| Baseline non-menstrual pelvic pain VRS*, mean (SD) | 1.78 (0.44) | 1.73 (0.46) | 1.80 (0.46) |
| Baseline dysmenorrhea VRS*, mean (SD) | 2.29 (0.43) | 2.25 (0.40) | 2.29 (0.43) |
| Baseline overall pelvic pain NRS, mean (SD) | 6.18 (1.51) | 5.84 (1.65) | 6.12 (1.60) |
| Baseline dyspareunia (VRS) mean (SD) | 1.95 (0.87) | 1.92 (0.86) | 2.09 (0.84) |
| Baseline EHP-30 pain dimension, mean (SD) | 51.77 (14.43) | 51.46 (14.28) | 52.37 (15.14) |
| Baseline analgesic use on bleeding days* (pill count/day), mean (SD) | 1.65 (1.45) | 1.88 (1.69) | 2.01 (1.95) |
| Baseline analgesic use on non-bleeding days* (pill count/day), mean (SD) | 0.78 (0.98) | 1.00 (1.23) | 1.08 (1.26) |
| Baseline dyschezia NRS, mean (SD) | 4.46 (2.51) | 3.73 (2.60) | 4.07 (2.79) |
| Baseline Lipid levels | |||
| LDL cholesterol (mg/dl), mean (SD) | 114.3 (31.8) | 117.4 (39.4) | 115.4 (32.1) |
| Triglycerides (mg/dl), mean (SD) | 91.9 (46.8) | 92.0 (48.5) | 90.0 (43.2) |
| Baseline BMD | |||
| Femoral neck (g/cm2), mean (SD) | 0.995 (0.141) | 0.980 (0.144) | |
| Lumbar spine (g/cm2), mean (SD) | 1.214 (0.140) | 1.197 (0.150) | 1.169 (0.134) |
| Total hip (g/cm2), mean (SD) | 1.031 (0.116) | 1.026 (0.127) | 1.015 (0.125) |
*
Based on the two selected screening menstrual cycles.
ABT: add-back therapy; BMD: bone mineral density; EHP-30: endometriosis health profile-30; LDL: low-density lipoprotein; NRS: numeric rating scale; VRS: verbal rating scale.