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Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.

NCT05620355 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2023-03-21

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Conditions

  • Uterine Fibroids
  • Heavy Menstrual Bleeding

Interventions

DRUG

BG2109

BG2109 100mg film coated tablet for oral administration once daily.

DRUG

Placebo for BG2109

Placebo for BG2109 100mg tablet for oral administration once daily.

DRUG

Placebo for add-back therapy

Placebo for add-back therapy tablet for oral administration once daily.

DRUG

Add-back therapy

Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration 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
2022-12-16
Primary Completion
2024-05-31
Completion
2025-03-31

Countries

  • China

Study Locations

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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 NCT05620355 on ClinicalTrials.gov