Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Summary

The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

Timeline

Start

2020-03-05

Primary completion

2022-09-15

Completion

2022-12-15

Publications

• Donnez J, Becker CM, Petraglia F, Horne AW, Becker S, Renner SP, Carmona Herrera F, Taylor HS, Paszkowski M, Bestel E, Hori S, Dolmans MM. Linzagolix, with and without add-back therapy, in women with endometriosis-associated pain: results from EDELWEISS 6, a double-blind randomized extension and withdrawal study. Hum Reprod Open. 2026 Apr 8;2026(2):hoag030. doi: 10.1093/hropen/hoag030. eCollection 2026.

Drugs

Indications