drugset / Trial / NCT03986944
A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
RandomizedParallel-groupQuadruple-blindTreatment
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
- 2019-05-23
- Primary completion
- 2021-01-06
- Completion
- 2021-02-16
Outcome
Outcome not reported
Stopped (Enrollment): “Study halted due to the significant enrollment challenges encountered since its beginning. Screening and enrollment have been impacted by the COVID pandemic and more importantly by changes in the diagnosis and treatment of women with endometriosis.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 1 mg | Oral |
| Subject | Norethindrone | Unknown | 0.5 mg | Oral |
| Subject | linzagolix | Unknown | 75 mg | Oral |
| Subject | linzagolix | Unknown | 200 mg | Oral |