Table 1.
Baseline Characteristics for Women Enrolled in Elaris EM-I and EM-II
| Characteristics | Placebo N = 734 | Elagolix 150 mg QD N = 475 | Elagolix 200 mg BID N = 476 |
|---|---|---|---|
| Age, years | 32 ± 6.6 | 32 ± 6.4 | 32 ± 6.6 |
| BMI, kg/m2 | 28 ± 6.3 | 28 ± 6.6 | 27 ± 6.6 |
| Dysmenorrhea score (scale, 0–3) | 2.2 ± 0.5 | 2.2 ± 0.5 | 2.1 ± 0.5 |
| No. of bleeding days | 8.4 ± 3.0 | 8.1 ± 2.9 | 8.2 ± 3.0 |
| Percent of bleeding days witha: | |||
| “None” dysmenorrhea | 1.7 | 2.2 | 2.4 |
| “Mild” dysmenorrhea | 18.0 | 16.3 | 17.9 |
| “Moderate/severe” dysmenorrhea | 80.4 | 81.5 | 79.7 |
| Nonmenstrual Pelvic Pain score (scale, 0–3)a | 1.6 ± 0.5 | 1.7 ± 0.5 | 1.6 ± 0.5 |
| No. of nonbleeding days | 22.7 ± 4.5 | 23.1 ± 4.1 | 22.5 ± 4.6 |
| Percent of nonbleeding days witha: | |||
| “None” nonmenstrual pelvic pain | 9.5 | 9.3 | 10.3 |
| “Mild” nonmenstrual pelvic pain | 34.5 | 31.0 | 35.2 |
| “Moderate/severe” nonmenstrual pelvic pain | 56.0 | 59.6 | 54.6 |
Notes: Data are presented as mean ± SD or number of patients (percentage). aPatients answered dysmenorrhea and nonmenstrual pelvic pain questions with a response of none (0), mild (1), moderate (2), or severe (3).
Abbreviations: BID, twice daily; BMI, body mass index; QD, once daily.