Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Summary

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

Timeline

Start

2019-06-13

Primary completion

2021-10-18

Completion

2022-04-01

Outcome

Mixed primary results

paper At 3 months, the daily 200 mg linzagolix dose with ABT met the primary efficacy objective PMID 38648863 ↗

paper The 75 mg linzagolix daily dose demonstrated a clinically meaningful and statistically significant reduction in dysmenorrhea versus placebo at 3 months. PMID 38648863 ↗

paper Although the 75 mg dose showed a trend toward reduction in non-menstrual pelvic pain at 3 months relative to the placebo, it was not statistically significant. PMID 38648863 ↗

Publications

• Donnez J, Becker C, Taylor H, Carmona Herrera F, Donnez O, Horne A, Paszkowski M, Petraglia F, Renner SP, Patel A, Boolell M, Bestel E, Dolmans MM. Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3). Hum Reprod. 2024 Jun 3;39(6):1208-1221. doi: 10.1093/humrep/deae076.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	linzagolix	Unknown	75 mg	Oral
Subject	linzagolix	Unknown	200 mg	Oral
Background	Estradiol	Other / unclassified	1 mg	Oral
Background	Norethindrone	Unknown	0.5 mg	Oral

Indications