Safety and efficacy of elagolix (with and without add-back therapy) for the treatment of heavy menstrual bleeding associated with uterine leiomyomas: a systematic review and meta-analysis

Ali, Mustafa; Hira, Aruna Kumari; Jawaid, Haris; Zakaria, Faiza; Somjee, Zehra

doi:10.1186/s43043-021-00064-5

Table 1 Basic study characteristics

From: Safety and efficacy of elagolix (with and without add-back therapy) for the treatment of heavy menstrual bleeding associated with uterine leiomyomas: a systematic review and meta-analysis

Study	Study design	Duration of treatment/follow-up	Country	Population	Intervention
Archer et al. (NCT01441635)	Phase 2a, dose-ranging, multiple-cohort study	- 3-month treatment - 3-month follow-up	USA (including Puerto Rico)	PBO = 50 Elagolix 100 BD = 33 Elagolix 200 BD = 35 Elagolix 300 BD = 30 Elagolix 400 QD = 32 Elagolix 600 QD = 30 E200 + 0.5E2/0.1NETA = 34 E300 + CEP = 26	Elagolix only = Elagolix 100 mg BD; Elagolix 200 mg BD; Elagolix 300 mg BD; Elagolix 400 mg QD; Elagolix 600 mg QD; Elagolix +ABT = Elagolix 300 mg + CEP (continuous low-dose 1.0 mg E2 continuously and cyclical oral Progesterone 200 mg); Elagolix 200 mg BD + 0.5 mg E2/0.1 mg NETA
Carr et al. (NCT01817530)	Phase 2b, double-blind, randomized, placebo-controlled, parallel-group study	- 6-month treatment - 6-month follow-up	United States (including Puerto Rico), Canada, Chile, and the United Kingdom	PBO = 65 Elagolix only = 65 Elagolix + 0.5E2/0.1NETA = 64 Elagolix + 1.0E2/0.5NETA = 65	Placebo Elagolix only = Elagolix 300 mg BD; Elagolix + ABT = Elagolix 300 mg + 0.5 mg E2/0.1 mg NETA; Elagolix 300 mg + 1.0 mg E2/0.5 mg NETA
Carr et al. (NCT01817530)		- 6-month treatment - 6-month follow-up		PBO = 78 Elagolix only = 77 Elagolix + 0.5E2/0.1NETA = 76 Elagolix + 1.0E2/0.5NETA = 77	Placebo Elagolix only = Elagolix 600 mg QD; Elagolix + ABT = Elagolix 600 mg + 1.0 mg E2/0.5 mg NETA; Elagolix + ABT = Elagolix 600 mg + 0.5 mg E2/0.1 mg NETA
Elaris UF-1 (NCT02654054)	Phase 3, double-blind, randomized, placebo-controlled	- 6-month treatment - 12-month follow-up	United States (including Puerto Rico)	PBO = 102 Elagolix only = 104 Elagolix + ABT = 206	Placebo Elagolix only = Elagolix 300 mg BD; Elagolix + ABT = Elagolix 300 mg + 1.0 mg E2/0.5 mg NETA
Elaris UF-2 (NCT02691494)	Phase 3, double-blind, randomized, placebo-controlled	- 6-month treatment - 12-month follow-up	USA (including Puerto Rico) and Canada	PBO = 94 Elagolix only = 95 Elagolix + ABT = 189	Placebo Elagolix only = Elagolix 300 mg BD; Elagolix + ABT = Elagolix 300 mg + 1.0 mg E2/0.5 mg NETA

E2/NETA E2 (estradiol) with norethindrone acetate

Back to article page