Table 2:

Clinical trials exploring elagolix efficacy in uterine fibroids associated bleeding

Trial	Type	Treatment groups	Enrolled patients	Treatment period	Primary Outcome Measures	Reference
NCT01441635	Phase IIa Placebo-controlled, dose-ranging, multiple cohort (completed)	Elagolix 300 mg twice daily ± add-back Elagolix 600 mg once daily Elagolix 200 mg twice daily ± add-back Elagolix 400 mg once daily Elagolix 100 mg twice daily Placebo	Elagolix alone, 160 Elagolix + add-back, 61 Placebo, 50 Total, 271	3 months	Mean Change from Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) using the alkaline hematin method	[30]
NCT01817530	Phase IIb Double-blind, placebo-controlled, parallel group (completed)	Elagolix 300 mg twice daily ± add-back Elagolix 600 mg once daily ± add-back Placebo	Elagolix alone, 142 Elagolix + add-back, 282 Placebo, 143 Total, 567	6 months	Percentage of women who had less than 80 mL menstrual blood loss and 50% or greater reduction in menstrual blood loss from baseline to the last 28 days of treatment. Safety assessments included changes in bone mineral density.	[31]
NCT02654054 (ELARIS UF-I)	Phase III Double-blind, placebo-controlled (completed)	Elagolix 300 mg twice daily Elagolix 300 mg twice daily ± add-back Placebo	Total 412	6 months	Percentage of responders, defined as participants who met the following conditions: - Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and - ≥ 50% reduction in MBL volume from Baseline to the Final Month.	[67]
NCT02691494 (ELARIS UF-II)	Phase III Double-blind, placebo-controlled (completed)	Elagolix 300 mg twice daily Elagolix 300 mg twice daily ± add-back Placebo	Total 378	6 months	Percentage of responders, defined as participants who met the following conditions: - Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and - ≥ 50% reduction in MBL volume from Baseline to the Final Month.	[67]
NCT02925494 (ELARIS UF-EXTEND)	Phase III Double-blind, placebo-controlled (completed)	Elagolix 300 mg twice daily ± add-back	Elagolix alone, 98 Elagolix + add-back, 218 Total 433	Additional 6 months after completion of 6 months in ELARIS UF-I or II	Percentage of responders, defined as participants who met the following conditions: - Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and - ≥ 50% reduction in MBL volume from Baseline to the Final Month. Safety evaluations included adverse events and bone mineral density changes. Safety evaluations included adverse events and bone mineral density changes.	[68]
NCT03271489	Phase IIIb, placebo-controlled, double-blinded in the first year and an open-label for the next three years (ongoing)	Elagolix + add-back Placebo	500 participants estimated	12 months	Change in Bone Mineral Density (BMD)
NCT03886220	Phase III Double-blind, placebo-controlled (ongoing)	Elagolix Placebo	48 participants estimated	6 months	Percentage of Participants with Menstrual Blood Loss (MBL) volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume from Baseline to the Final Month