Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Phase 2 Completed 118 enrolled AbbVie

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Timeline

Start: 2019-08-12
Primary completion: 2021-02-10
Completion: 2021-02-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Elagolix 25 mg BID; p = 0.300; Adjusted Response Rate Difference -5.9 (90% CI -15.38 to 3.49) NCT03951077 ↗

paper No significant improvement in restoring normal menstrual cycles was observed in treated subjects; 3 of 114 patients met the primary endpoint. PMID 37398623 ↗

Publications

Snabes MC, Ng J, Li H, Ali I, Shebley M, Schlaff WD. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. F S Rep. 2023 Feb 21;4(2):206-212. doi: 10.1016/j.xfre.2023.02.007. eCollection 2023 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elagolix	Small molecule	25 mg	Oral
Subject	Elagolix	Small molecule	50 mg	Oral
Subject	Elagolix	Small molecule	75 mg	Oral
Subject	Elagolix	Small molecule	150 mg	Oral
Subject	Elagolix	Small molecule	300 mg	Oral