NCT05894135

Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of BG2109 administered orally once daily at doses of 100 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in chinese women with surgically confirmed endometriosis. The entire study is divided into the core stage and the extension stage, with a total duration of approximately 72 weeks. This includes the prescreening wash-out period (if applicable), screening period (approximately 5-8 weeks), core stage (24 weeks) and extension stage (28 weeks), and the safety follow-up period (approximately 12 weeks)

Conditions

• Endometriosis
• Moderate to Severe Endometriosis-associated Pain

Interventions

Type	Name	Description
DRUG	BG2109 100mg	One tablet of BG2109 100mg , oral , once daily
DRUG	BG2109 200mg	One tablet of BG2109 200mg, oral , once daily.
DRUG	ABT(E2 1 mg / NETA 0.5 mg)	One tablet of ABT(E2 1 mg / NETA 0.5 mg), oral, once-daily
DRUG	BG2109 100mg Placebo	One tablet of BG2109 100mg Placebo, oral , once daily.
DRUG	BG2109 200mg Placebo	One tablet of BG2109 200mg Placebo, oral , once daily.
DRUG	ABT Placebo	One tablet of ABT Placebo, oral, once-daily

Timeline

• Start date: 2023-07-14
• Primary completion: 2024-06-01
• Completion: 2025-03-01
• First posted: 2023-06-08
• Last updated: 2023-07-27

Locations

1 site across 1 country: China