MedTrace Logo

Efficacy and Safety of BG2109 in Chinese Subjects With Endometriosis

NCT05894135 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-07-27

No results posted yet for this study

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

Conditions

  • Endometriosis
  • Moderate to Severe Endometriosis-associated Pain

Interventions

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

Sponsors & Collaborators

  • Bio Genuine (Shanghai) Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Congjian Xu · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2024-06-30
Completion
2025-03-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894135 on ClinicalTrials.gov