A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis
Sponsor study identifier
interventional
540
1 country
1
Study Start
July 14, 2023
Actual (reported)Primary Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 9, 2023
Actual (reported)June 8, 2023
Actual (reported)July 14, 2023
Actual (reported)June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Dysmenorrhea (DYS) response rate at Week 12
responders are defined as those with a significant decrease in mean DYS score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP
Week 12
Non-menstrual pelvic pain (NMPP) response rate at Week 12
responders are defined as those with a significant decrease in mean NMPP score measured using Numeric Rating Scale - NRS(0-10, higher scores mean worse) compared to baseline, with decreased or stable analgesic use for EAP
Week 12
Change of the interference of pain with the ability to perform daily activities from the baseline at week 24
Week 24
Change of the mean overall pelvic pain(OPP) score from the baseline at week 24
Week 24
Change of the mean DYS score from the baseline at week 24
Week 24
Change of the mean NMPP score from the baseline at week 24
Week 24
Ratio of subjects who do not use analgesics to treat EAP at week 24
Week 24
Change of mean pelvic pain scores of DYS from the baseline to each scheduled assessment
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Change of mean pelvic pain scores of NMPP from the baseline to each scheduled assessment
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
Change of mean pelvic pain scores of overall pelvic pain(OPP) from the baseline to each scheduled assessment
during the previous 35 days of Week 4,8,12,24,28,32,36,52,56,64
One tablet of BG2109 100mg , oral , once daily
One tablet of BG2109 200mg, oral , once daily.
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Congjian Xu
Obstetrics & Gynecology Hospital of Fudan University
First Submitted
May 9, 2023
First Posted
June 8, 2023
Study Start
July 14, 2023
Actual (reported)Primary Completion
June 2024
Estimated (date passed)One tablet of ABT(E2 1 mg / NETA 0.5 mg), oral, once-daily
One tablet of BG2109 100mg Placebo, oral , once daily.
One tablet of BG2109 200mg Placebo, oral , once daily.
One tablet of ABT Placebo, oral, once-daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 27, 2023
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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