drugset / Trial / NCT05894135
Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this study is to demonstrate the efficacy and safety of BG2109 administered orally once daily at a dose of 100 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, while under randomized treatment, in the management of moderate to severe endometriosis-associated pain (EAP) in chinese women with surgically confirmed endometriosis
Timeline
- Start
- 2023-07-14
- Primary completion
- 2024-06
- Completion
- 2025-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BG2109 | Unknown | 100 mg | Oral |
| Subject | BG2109 | Unknown | 200 mg | Oral |
| Background | Estradiol | Other / unclassified | 1 mg | Oral |
| Background | Norethindrone | Unknown | 0.5 mg | Oral |