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

Last updated: March 19, 2023
Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Hemorrhage

Uterine Fibroids

Menstrual Disorders

Treatment

N/A

Clinical Study ID

NCT05620355
BG2109-301
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Subject is an 18 years and older premenopausal woman.
  2. Subject's Body Mass Index ≥ 18 kg/m2.
  3. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound.
  4. Subject's menstrual cycles is between 21 days and 35 days in the last 3 months.
  5. Subject has clinical manifestations of heavy menstrual bleeding.
  6. Subject's menstrual blood loss >80mL for at least 2 menstrual periods assessed atscreening using the alkaline hematin method.

Exclusion

Key Exclusion Criteria:

  1. The subject is pregnant or breast-feeding or is planning a pregnancy within theduration of the treatment period of the study.
  2. The subject has a history of uterus surgery that would interfere with the study.
  3. The subject's condition is so severe that she will require surgery within 6 months.
  4. The subject have had or are currently suffering from any estrogen- dependentmalignancy.
  5. The subject has a significant risk of osteoporosis, or have a known history ofosteoporosis or other metabolic bone disease.

Study Design

Total Participants: 312
Study Start date:
December 16, 2022
Estimated Completion Date:
March 31, 2025

Study Description

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of BG2109 alone and in combination with add-back therapy (Estradiol 1 mg / Norethindrone Acetate 0.5 mg) for the treatment of uterine fibroids in China.

Connect with a study center

  • Site no.28

    Beijing,
    China

    Site Not Available

  • Site no.31

    Beijing,
    China

    Site Not Available

  • Site no.34

    Beijing,
    China

    Site Not Available

  • Site no.11

    Changchun,
    China

    Site Not Available

  • Site no.6

    Changsha,
    China

    Site Not Available

  • Site no.7

    Changsha,
    China

    Site Not Available

  • Site no.17

    Chengdu,
    China

    Site Not Available

  • Site no.22

    Chengdu,
    China

    Site Not Available

  • Site no.10

    Chongqing,
    China

    Site Not Available

  • Site no.3

    Guangzhou,
    China

    Site Not Available

  • Site no.4

    Guangzhou,
    China

    Site Not Available

  • Site no.19

    Hangzhou,
    China

    Active - Recruiting

  • Site no.21

    Jinan,
    China

    Active - Recruiting

  • Site no.23

    Lianyungang,
    China

    Active - Recruiting

  • Site no.14

    Nanjing,
    China

    Site Not Available

  • Site no.15

    Nanjing,
    China

    Site Not Available

  • Site no.16

    Nanjing,
    China

    Site Not Available

  • Site no.26

    Nanjing,
    China

    Site Not Available

  • Site no.1

    Shanghai,
    China

    Active - Recruiting

  • Site no.18

    Shanghai,
    China

    Site Not Available

  • Site no.29

    Shanghai,
    China

    Active - Recruiting

  • Site no.8

    Shenyang,
    China

    Site Not Available

  • Site no.30

    Shenzhen,
    China

    Site Not Available

  • Site no.5

    Taiyuan,
    China

    Site Not Available

  • Site no.2

    Tianjin,
    China

    Site Not Available

  • Site no.20

    Wenzhou,
    China

    Site Not Available

  • Site no.25

    Wuhan,
    China

    Site Not Available

  • Site no.13

    Xi'an,
    China

    Site Not Available

  • Site no.32

    Zhengzhou,
    China

    Site Not Available

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