Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data

Figures & data

Figure 1 Chemical structure and molecular formula of elagolix.

Table 1 Therapeutic Clinical Trials On Elagolix For The Treatment Of UFs

Study Identifier	Phase	Type	Status	Arms Of Treatment	Randomized Patients	Treatment Period
NCT01441635	IIa	Placebo-controlled, dose-ranging, multiple-cohort	Completed, with published results^Citation64	Elagolix 300 mg twice daily ± add-back^a Elagolix 600 mg once daily Elagolix 200 mg twice daily ± add-back^b Elagolix 400 mg once daily Elagolix 100 mg twice daily Placebo	Elagolix alone, 160 Elagolix + add-back, 61 Placebo, 50 Total, 271	3 months
NCT01817530	IIb	Double-blind, placebo-controlled, parallel-group	Completed, with published results^Citation65	Elagolix 300 mg twice daily ± add-back^c Elagolix 600 mg once daily ± add-back^c Placebo	Elagolix alone, 142 Elagolix + add-back, 282 Placebo, 143 Total, 567	6 months
NCT02654054 (ELARIS UF-I)	III	Double-blind, placebo-controlled	Completed, waiting for definitive results	Elagolix 300 mg twice daily ± add-back^d Placebo	Not available	6 months
NCT02691494(ELARIS UF-II)	III	Double-blind, placebo-controlled	Completed, waiting for definitive results	Elagolix 300 mg twice daily ± add-back^d Placebo	Not available	6 months
NCT02925494(ELARIS UF-EXTEND)	III	Randomized, double-blind, active treatment	Completed, waiting for definitive results	Elagolix 300 mg twice daily ± add-back^d	Not available	6 additional months
NCT03271489	IIIb	Double-blind, placebo-controlled	Ongoing	Elagolix + add-back Placebo	600 participants estimated	12 months
NCT03886220	III	Double-blind, placebo-controlled	Ongoing	Elagolix Placebo	150 participants estimated	6 months

Notes: ^aEstradiol 1 mg continuously and cyclical oral progesterone 200 mg; ^b0.5 mg estradiol/0.1 mg norethindrone acetate continuously; ^c0.5 mg estradiol/0.1 mg norethindrone acetate or 1 mg estradiol/0.5 mg norethindrone acetate; ^d1 mg estradiol/0.5 mg norethindrone acetate.

Table 2 Endpoints And Safety Assessment Of Phase II And III Clinical Trials On Elagolix For The Treatment Of Heavy Menstrual Bleeding-Associated With Uterine Fibroids

Primary endpoint	percentage of women with reduction in MBL to <80 mL and ≥50% from baseline
Secondary endpoint	percentage of women with amenorrhea and suppression of bleeding mean change from baseline in the number of bleeding and heavy bleeding days percentage of women who had a 1 g/dL or greater increase in hemoglobin concentration mean change from baseline in hemoglobin concentration mean change from baseline in fibroids and uterine volume mean change from baseline in Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire score
Safety assessment	adverse events monitoring vital signs, electrocardiogram and physical examination clinical laboratory tests (hematology, chemistry, urinalysis, lipid panel) bone mineral density assessment (dual-energy X-ray absorptiometry scans) endometrial assessment (tissue biopsy and transvaginal ultrasound)

Abbreviation: MBL, menstrual blood loss.

Archer DF, Stewart EA, Jain RI, et al. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study. Fertil Steril. 2017;108(1):152–160.e4. doi:10.1016/j.fertnstert.2017.05.00628579415

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Carr BR, Stewart EA, Archer DF, et al. Elagolix alone or with add-back therapy in women with heavy menstrual bleeding and uterine leiomyomas: a randomized controlled trial. Obstet Gynecol. 2018;132(5):1252–1264. doi:10.1097/AOG.000000000000293330303923

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