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. 2021 Jun 16;21:246. doi: 10.1186/s12905-021-01385-3

Table 1.

Numeric rating scalea changes from baseline to month 3 for integrated Elaris EM-I and II

Parameter Treatment N LS means (SE) LS mean of difference (SE) 97.5% CI Two-sided p valueb
Age
 < 25 years
Placebo 75  − 1.13 (0.197)
150 mg QD 55  − 1.78 (0.242)  − 0.65 (0.312) (− 1.35, 0.05) 0.037*
200 mg BID 58  − 1.87 (0.232)  − 0.75 (0.304) (− 1.43, − 0.06) 0.014*
25–35 years
Placebo 361  − 1.06 (0.092)
150 mg QD 248  − 1.83 (0.112)  − 0.77 (0.144) (− 1.09, − 0.45)  < 0.001***
200 mg BID 226  − 2.50 (0.117)  − 1.44 (0.149) (− 1.77, − 1.10)  < 0.001***
 > 35 years
Placebo 205  − 1.50 (0.123)
150 mg QD 127  − 1.80 (0.157)  − 0.30 (0.200) (− 0.75, 0.15) 0.130
200 mg BID 138  − 2.66 (0.151)  − 1.16 (0.194) (− 1.59, − 0.72)  < 0.001***
BMI (kg/m2)
 < 25
Placebo 255  − 1.31 (0.109)
150 mg QD 164  − 1.72 (0.137)  − 0.40 (0.175) (− 0.79, − 0.01) 0.022*
200 mg BID 178  − 2.31 (0.132)  − 1.00 (0.171) (− 1.38, − 0.61)  < 0.001***
 ≥ 25–29
Placebo 178  − 1.13 (0.130)
150 mg QD 130  − 1.93 (0.157)  − 0.80 (0.204) (− 1.26, − 0.34)  < 0.001***
200 mg BID 114  − 2.79 (0.166)  − 1.66 (0.211) (− 2.13, − 1.18)  < 0.001***
 ≥ 30
Placebo 205  − 1.14 (0.124)
150 mg QD 134  − 1.84 (0.154)  − 0.70 (0.197) (− 1.14, − 0.26)  < 0.001***
200 mg BID 127  − 2.36 (0.157)  − 1.23 (0.200) (− 1.68, − 0.78)  < 0.001***
Race
White
Placebo 568  − 1.20 (0.074)
150 mg QD 380  − 1.78 (0.091)  − 0.58 (0.117) (− 0.84, − 0.31)  < 0.001***
200 mg BID 376  − 2.45 (0.091)  − 1.24 (0.117) (− 1.51, − 0.98)  < 0.001***
Black
Placebo 52  − 1.28 (0.243)
150 mg QD 38  − 2.04 (0.289)  − 0.76 (0.377) (− 1.61, 0.08) 0.043*
200 mg BID 35  − 2.53 (0.294)  − 1.24 (0.381) (− 2.10, − 0.39) 0.001***
Other
Placebo 21  − 1.13 (0.372)
150 mg QD 12  − 2.30 (0.524)  − 1.17 (0.643) (− 2.61, 0.28) 0.070
200 mg BID 11  − 2.85 (0.538)  − 1.72 (0.654) (− 3.18, − 0.25) 0.009**
Ethnicity
Hispanic/latino
Placebo 92  − 1.53 (0.181)
150 mg QD 64  − 2.04 (0.224)  − 0.51 (0.288) (− 1.16, 0.14) 0.077
200 mg BID 64  − 2.58 (0.220)  − 1.05 (0.285) (− 1.69, − 0.41)  < 0.001***
Other
Placebo 549  − 1.15 (0.075)
150 mg QD 366  − 1.78 (0.092)  − 0.63 (0.119) (− 0.89, − 0.36)  < 0.001***
200 mg BID 358  − 2.44 (0.093)  − 1.29 (0.120) (− 1.56, − 1.02)  < 0.001***
Baseline dysmenorrhea
 < Median = 2.17
Placebo 321  − 1.03 (0.099)
150 mg QD 209  − 1.67 (0.123)  − 0.63 (0.157) (− 0.99, − 0.28)  < 0.001***
200 mg BID 220  − 2.25 (0.121)  − 1.22 (0.154) (− 1.56, − 0.87)  < 0.001***
 ≥ Median = 2.17
Placebo 320  − 1.38 (0.099)
150 mg QD 221  − 1.97 (0.121)  − 0.59 (0.154) (− 0.93, − 0.24)  < 0.001***
200 mg BID 202  − 2.70 (0.125)  − 1.31 (0.157) (− 1.67, − 0.96)  < 0.001***
Baseline NMPP
 < Median = 1.54
Placebo 320  − 1.04 (0.103)
150 mg QD 208  − 1.73 (0.127)  − 0.68 (0.157) (− 1.04, − 0.33)  < 0.001***
200 mg BID 228  − 2.22 (0.122)  − 1.17 (0.152) (− 1.51, − 0.83)  < 0.001***
 ≥ Median = 1.54
Placebo 321  − 1.37 (0.103)
150 mg QD 222  − 1.90 (0.124)  − 0.53 (0.153) (− 0.88, − 0.19)  < 0.001***
200 mg BID 194  − 2.75 (0.131)  − 1.38 (0.160) (− 1.74, − 1.02)  < 0.001***
Baseline dyspareunia
 < Median = 1.40
Placebo 260  − 1.09 (0.109)
150 mg QD 174  − 1.72 (0.134)  − 0.63 (0.172) (− 1.02, − 0.25)  < 0.001***
200 mg BID 171  − 2.34 (0.135)  − 1.25 (0.172) (− 1.64, − 0.87)  < 0.001***
 ≥ Median = 1.40
Placebo 266  − 1.30 (0.108)
150 mg QD 181  − 1.80 (0.133)  − 0.50 (0.169) (− 0.88, − 0.12) 0.003**
200 mg BID 169  − 2.64 (0.136)  − 1.33 (0.172) (− 1.72, − 0.95)  < 0.001***
Baseline analgesic use
None
Placebo 48  − 1.47 (0.244)
150 mg QD 55  − 1.48 (0.243)  − 0.01 (0.344) (− 0.78, 0.77) 0.986
200 mg BID 32  − 2.88 (0.310)  − 1.41 (0.394) (− 2.29, − 0.53)  < 0.001***
Opioid only
Placebo 116  − 0.74 (0.162)
150 mg QD 77  − 1.86 (0.205)  − 1.12 (0.261) (− 1.71, − 0.54)  < 0.001***
200 mg BID 71  − 2.17 (0.208)  − 1.43 (0.264) (− 2.02, − 0.83)  < 0.001***
NSAID only
Placebo 212  − 1.41 (0.120)
150 mg QD 127  − 2.24 (0.156)  − 0.83 (0.197) (− 1.27, − 0.39)  < 0.001***
200 mg BID 134  − 2.49 (0.152)  − 1.08 (0.194) (− 1.52, − 0.65)  < 0.001***
Both
Placebo 265  − 1.19 (0.106)
150 mg QD 171  − 1.58 (0.133)  − 0.39 (0.170) (− 0.77, − 0.01) 0.021*
200 mg BID 185  − 2.49 (0.129)  − 1.30 (0.168) (− 1.68, − 0.93)  < 0.001***
Time since endometriosis diagnosis
 < 2 years
Placebo 214  − 1.29 (0.119)
150 mg QD 174  − 1.66 (0.135)  − 0.37 (0.180) (− 0.77, 0.04) 0.042*
200 mg BID 138  − 2.52 (0.151)  − 1.23 (0.193) (− 1.67, − 0.80)  < 0.001***
2–5 years
Placebo 235  − 1.16 (0.114)
150 mg QD 146  − 1.85 (0.148)  − 0.69 (0.187) (− 1.11, − 0.27)  < 0.001***
200 mg BID 155  − 2.35 (0.142)  − 1.19 (0.182) (− 1.60, − 0.78)  < 0.001***
 ≥ 5 years
Placebo 192  − 1.17 (0.126)
150 mg QD 110  − 2.02 (0.168)  − 0.85 (0.210) (− 1.32, − 0.38)  < 0.001***
200 mg BID 128  − 2.54 (0.157)  − 1.37 (0.201) (− 1.82, − 0.92)  < 0.001***
Previous GnRH therapy
No
Placebo 476  − 1.27 (0.080)
150 mg QD 319  − 1.97 (0.099)  − 0.70 (0.127) (− 0.99, − 0.41)  < 0.001***
200 mg BID 309  − 2.49 (0.100)  − 1.22 (0.128) (− 1.51, − 0.93)  < 0.001***
Yes
Placebo 165  − 1.03 (0.136)
150 mg QD 111  − 1.39 (0.167)  − 0.36 (0.215) (− 0.84, 0.12) 0.095
200 mg BID 113  − 2.41 (0.166)  − 1.38 (0.214) (− 1.86, − 0.90)  < 0.001***
Entered washout
No
Placebo 470  − 1.24 (0.080)
150 mg QD 328  − 1.86 (0.098)  − 0.62 (0.126) (− 0.90, − 0.33)  < 0.001***
200 mg BID 316  − 2.43 (0.099)  − 1.19 (0.128) (− 1.47, − 0.90)  < 0.001***
Yes
Placebo 171  − 1.10 (0.135)
150 mg QD 102  − 1.66 (0.177)  − 0.56 (0.223) (− 1.06, − 0.06) 0.013*
200 mg BID 106  − 2.58 (0.173)  − 1.48 (0.220) (− 1.97, − 0.99)  < 0.001***
History of pregnancy
No
Placebo 278  − 1.28 (0.099)
150 mg QD 173  − 1.80 (0.126)  − 0.52 (0.160) (− 0.88, − 0.16) 0.001***
200 mg BID 184  − 2.21 (0.121)  − 0.94 (0.157) (− 1.29, − 0.58)  < 0.001***
Yes
Placebo 363  − 1.15 (0.086)
150 mg QD 257  − 1.82 (0.105)  − 0.66 (0.135) (− 0.97, − 0.36)  < 0.001***
200 mg BID 238  − 2.68 (0.108)  − 1.53 (0.138) (− 1.84, − 1.22)  < 0.001***

BID twice daily, BMI body mass index, EM-I/II Elaris endometriosis studies I and II, GnRH gonadotropin-releasing hormone, LS least squares, NMPP non-menstrual pelvic pain, NSAID non-steroidal anti-inflammatory drug, QD once daily

aPain scale ranges from 0 (none) to 10 (worst pain ever)

bp value for test of difference between each elagolix dosage group and placebo is from a mixed-effects model using repeated measures with treatment as the main effect, visit number as the repeated measure, baseline value, visit, subgroup, treatment by visit, subgroup by treatment, subgroup by visit, and subgroup by treatment by visit as covariates

*p < 0.05, **p < 0.01, and ***p < 0.001