drugset / Trial / NCT04372121
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
RandomizedParallel-groupQuadruple-blindTreatment
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
- 2020-03-23
- Primary completion
- 2021-01-08
- Completion
- 2021-02-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | E2 | Unknown | 1 mg | Oral |
| Subject | NETA | Unknown | 0.5 mg | Oral |
| Subject | linzagolix | Unknown | 75 mg | Oral |
| Subject | linzagolix | Unknown | 200 mg | Oral |