A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

Summary

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Timeline

Start

2017-07-07

Primary completion

2020-03-27

Completion

2023-12-06

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Elagolix + E2/NETA; p < 0.001; Odds Ratio (OR) 5.51 (95% CI 3.711 to 8.176); NCT03213457 ↗

registry analysis (superiority test); Placebo vs Elagolix + E2/NETA; p < 0.001; Odds Ratio (OR) 4.33 (95% CI 2.968 to 6.331); NCT03213457 ↗

registry analysis (superiority test); Placebo vs Elagolix + E2/NETA; p < 0.001; Odds Ratio (OR) 1.82 (95% CI 1.275 to 2.605); NCT03213457 ↗

registry analysis (superiority test); Placebo vs Elagolix + E2/NETA; p = 0.007; Odds Ratio (OR) 1.63 (95% CI 1.146 to 2.326); NCT03213457 ↗

Publications

• Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elagolix	Small molecule	200 mg	—
Subject	Estradiol/Norethindrone Acetate	Unknown	0.5 mg	—
Subject	Estradiol/Norethindrone Acetate	Unknown	1 mg	—

Indications