Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of BG2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women.
1 other identifier
interventional
312
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2022
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 17, 2022
CompletedStudy Start
First participant enrolled
December 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 21, 2023
March 1, 2023
1.4 years
November 10, 2022
March 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24.
MBL will be determined using the Alkaline Hematin method (AHM). Responder means whose MBL less than 80mL during the last 28 days before the Week 24 and more than 50% reduction in MBL compared to the baseline.
The last 28 days before the Week 24.
Secondary Outcomes (5)
Time to reduced MBL before the Week 24.
From baseline to Week 24.
Percentage of amenorrhea at the Week 24.
From baseline to Week 24.
Time to amenorrhea before the Week 24.
From baseline to Week 24.
Days of menstrual bleeding in the last 28 days before the Week 24.
The last 28 days before the Week 24.
Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
The Week 24.
Other Outcomes (8)
Percentage of Responders at the Week 52.
The last 28 days before the Week 52.
Time to reduced MBL before the Week 52.
From baseline to Week 52.
Percentage of amenorrhea at the Week 52.
From baseline to Week 52.
- +5 more other outcomes
Study Arms (3)
BG2109 100mg group
EXPERIMENTALOne tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
BG2109 200mg+ABT group
EXPERIMENTALTwo tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
Placebo group
PLACEBO COMPARATORTwo tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
Interventions
BG2109 100mg film coated tablet for oral administration once daily.
Placebo for BG2109 100mg tablet for oral administration once daily.
Placebo for add-back therapy tablet for oral administration once daily.
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Eligibility Criteria
You may qualify if:
- Subject is an 18 years and older premenopausal woman.
- Subject's Body Mass Index ≥ 18 kg/m2.
- Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound.
- Subject's menstrual cycles is between 21 days and 35 days in the last 3 months.
- Subject has clinical manifestations of heavy menstrual bleeding.
- Subject's menstrual blood loss \>80mL for at least 2 menstrual periods assessed at screening using the alkaline hematin method.
You may not qualify if:
- The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
- The subject has a history of uterus surgery that would interfere with the study.
- The subject's condition is so severe that she will require surgery within 6 months.
- The subject have had or are currently suffering from any estrogen- dependent malignancy.
- The subject has a significant risk of osteoporosis, or have a known history of osteoporosis or other metabolic bone disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Site no.28
Beijing, China
Site no.31
Beijing, China
Site no.34
Beijing, China
Site no.11
Changchun, China
Site no.6
Changsha, China
Site no.7
Changsha, China
Site no.17
Chengdu, China
Site no.22
Chengdu, China
Site no.10
Chongqing, China
Site no.3
Guangzhou, China
Site no.4
Guangzhou, China
Site no.19
Hangzhou, China
Site no.21
Jinan, China
Site no.23
Lianyungang, China
Site no.14
Nanjing, China
Site no.15
Nanjing, China
Site no.16
Nanjing, China
Site no.26
Nanjing, China
Site no.18
Shanghai, China
Site no.1
Shanghai, China
Site no.29
Shanghai, China
Site no.8
Shenyang, China
Site no.30
Shenzhen, China
Site no.5
Taiyuan, China
Site no.2
Tianjin, China
Site no.20
Wenzhou, China
Site no.25
Wuhan, China
Site no.13
Xi'an, China
Site no.32
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Congjian Xu
Obstetrics & Gynecology Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 17, 2022
Study Start
December 16, 2022
Primary Completion
May 1, 2024
Study Completion
March 1, 2025
Last Updated
March 21, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share