Table 2.

Reduction in Rescue Medication Use and Improvement in Dyspareunia by Elagolix Dose in Two Placebo-controlled Phase 3 Clinical Trials

Parameter	Elaris EM-I			Elaris EM-II
	Placebo	Elagolix, 150 mg once daily	Elagolix, 200 mg twice daily	Placebo	Elagolix, 150 mg once daily	Elagolix, 200 mg twice daily
Score for dyspareuniaa
At 3 months
No. of women	246	171	153	226	145	150
Change in score	–0.29 ± 0.04	–0.39 ± 0.05	–0.49 ± 0.05	–0.30 ± 0.04	–0.39 ± 0.05	–0.60 ± 0.05
Difference from placebo	—	–0.09 ± 0.07	–0.20 ± 0.07b	—	–0.09 ± 0.07	–0.30 ± 0.07c
Use of rescue analgesic agentd
At 3 months
No. of women	329	226	213	312	204	209
Change in score	–0.29 ± 0.03	–0.29 ± 0.04	–0.55 ± 0.04	–0.31 ± 0.03	–0.36 ± 0.04	–0.49 ± 0.03
Difference from placebo	—	–0.01 ± 0.05	–0.26 ± 0.05c	—	–0.05 ± 0.04	–0.18 ± 0.04c
At 6 months
No. of women	288	198	182	273	185	187
Change in score	–0.27 ± 0.04	–0.35 ± 0.04	–0.56 ± 0.05	–0.32 ± 0.03	–0.40 ± 0.04	–0.52 ± 0.04
Difference from placebo	—	–0.07 ± 0.06	–0.28 ± 0.06c	—	–0.08 ± 0.05	–0.21 ± 0.05c
Use of rescue opioidd
At 3 months
No. of women	329	226	213	312	204	209
Change in score	–0.10 ± 0.02	–0.07 ± 0.03	–0.22 ± 0.03	–0.12 ± 0.02	–0.12 ± 0.02	–0.21 ± 0.02
Difference from placebo	—	0.03 ± 0.04	–0.12 ± 0.04b	—	0.00 ± 0.03	–0.08 ± 0.03b

Reproduced with permission from Taylor et al.²⁶ Data are least-squares means ± SE.

^aPain scores range from 0 (none) to 3 (severe) and were recorded in a daily electronic diary. Scores on the scale for dyspareunia were analyzed for women who recorded data other than “not applicable” at baseline and at one or more measurements after baseline.

^bp < 0.01.

^cp < 0.001.

^dThe use of rescue NSAIDs or opioids was based on average pill counts.

SE, standard error.