Trial Title:
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
NCT ID:
NCT05620355
Condition:
Uterine Fibroids
Heavy Menstrual Bleeding
Conditions: Official terms:
Leiomyoma
Myofibroma
Menorrhagia
Hemorrhage
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
BG2109
Description:
BG2109 100mg film coated tablet for oral administration once daily.
Arm group label:
BG2109 100mg group
Arm group label:
BG2109 200mg+ABT group
Intervention type:
Drug
Intervention name:
Placebo for BG2109
Description:
Placebo for BG2109 100mg tablet for oral administration once daily.
Arm group label:
BG2109 100mg group
Arm group label:
Placebo group
Intervention type:
Drug
Intervention name:
Placebo for add-back therapy
Description:
Placebo for add-back therapy tablet for oral administration once daily.
Arm group label:
BG2109 100mg group
Arm group label:
Placebo group
Intervention type:
Drug
Intervention name:
Add-back therapy
Description:
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Arm group label:
BG2109 200mg+ABT group
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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 at
screening using the alkaline hematin method.
Key Exclusion Criteria:
1. The subject is pregnant or breast-feeding or is planning a pregnancy within the
duration 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- dependent
malignancy.
5. The subject has a significant risk of osteoporosis, or have a known history of
osteoporosis or other metabolic bone disease.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Site no.28
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.31
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.34
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.11
Address:
City:
Changchun
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.6
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.7
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.17
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.22
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.10
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.3
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.4
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.19
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Site no.21
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Facility:
Name:
Site no.23
Address:
City:
Lianyungang
Country:
China
Status:
Recruiting
Facility:
Name:
Site no.14
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.15
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.16
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.26
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.18
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.1
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Site no.29
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Site no.8
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.30
Address:
City:
Shenzhen
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.5
Address:
City:
Taiyuan
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.2
Address:
City:
Tianjin
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.20
Address:
City:
Wenzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.25
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.13
Address:
City:
Xi'an
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Site no.32
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Start date:
December 16, 2022
Completion date:
March 2025
Lead sponsor:
Agency:
Bio Genuine (Shanghai) Biotech Co., Ltd.
Agency class:
Industry
Source:
Bio Genuine (Shanghai) Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620355
