Table 1.
Demographics and Baseline Characteristics.
| Variable | Elagolix 150 mg Every Day (N = 84) | Elagolix 75 mg Twice a Day (N = 84) | DMPA-SC |
|---|---|---|---|
| Age, mean (SEM), years | 32.4 (0.8) | 31.4 (0.7) | 31.6 (0.4) |
| Race, n (%) | |||
| Caucasian | 68 (81.0) | 70 (83.3) | 65 (77.4) |
| African American | 6 (7.1) | 10 (11.9) | 10 (11.9) |
| Hispanic | 8 (9.5) | 4 (4.8) | 6 (7.1) |
| Other | 2 (2.4) | 0 (0.0) | 3 (3.6) |
| Weight, mean (SEM), kg | 72.1 (1.7) | 68.9 (1.5) | 70.9 (1.6) |
| Body mass index, mean (SEM), kg/m2 | 26.5 (0.5) | 25.4 (0.5) | 26.2 (0.5) |
| Length of screening phase menstrual cycle,a mean (SEM), days | 29.4 (0.8) | 28.3 (0.4) | 29.4 (0.6) |
| Stage of endometriosis,b,c n (%) | |||
| I | 21 (25.0) | 15 (17.9) | 23 (27.4) |
| II | 18 (21.4) | 20 (23.8) | 26 (31.0) |
| III | 17 (20.2) | 33 (39.3) | 22 (26.2) |
| IV | 15 (17.9) | 5 (6.0) | 6 (7.1) |
| Unknown | 13 (15.5) | 11 (13.1) | 7 (8.3) |
| Months since diagnosis of endometriosis,d mean (SEM) | 53.4 (5.5) | 54.1 (6.1) | 51.6 (5.3) |
Abbreviations: DMPA-SC, subcutaneous depot medroxyprogesterone acetate; SEM, standard error of the mean.
aThe number of days from the start date of the menses before screening to the start date of the menses before first dose.
bStage of endometriosis: 1: minimal, few, or superficial implants are evident; II: mild, more implants, and deeper involvement; III: moderate, more implants, with ovaries affected, and the presence of adhesions; IV: severe, as stage III but with multiple and more dense adhesions (based on the Revised American Society of Reproductive Medicine [ASRM] Classification of Endometriosis, 1996).
cStage and depth of endometriosis are based on evaluation at the time of laparoscopy and not at baseline.
dNumber of months relative to the date of informed consent.