Back to resultsEfficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
Primary Purpose
Uterine Fibroids, Heavy Menstrual Bleeding
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
BG2109
Placebo for BG2109
Placebo for add-back therapy
Add-back therapy
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
Sites / Locations
- Site no.28
- Site no.31
- Site no.34
- Site no.11
- Site no.6
- Site no.7
- Site no.17
- Site no.22
- Site no.10
- Site no.3
- Site no.4
- Site no.19Recruiting
- Site no.21Recruiting
- Site no.23Recruiting
- Site no.14
- Site no.15
- Site no.16
- Site no.26
- Site no.18
- Site no.1Recruiting
- Site no.29Recruiting
- Site no.8
- Site no.30
- Site no.5
- Site no.2
- Site no.20
- Site no.25
- Site no.13
- Site no.32
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BG2109 100mg group
BG2109 200mg+ABT group
Placebo group
Arm Description
One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to reduced MBL before the Week 24.
Reduced MBL means MBL less than 80ml and more than 50% reduction in MBL compared to the baseline.
Percentage of amenorrhea at the Week 24.
Amenorrhea is defined as having 0 data (or volume below the lower limit of quantification) from the AHM of MBL from the central laboratory or missing of AHM data with reported of "spotting" or "no bleeding" in the eDiary for 35 days before Week 24.
Time to amenorrhea before the Week 24.
The number of days from Study Day 1 to the first day having amenorrhea.
Days of menstrual bleeding in the last 28 days before the Week 24.
Record the number of days.
Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
Anemia is defined as hemoglobin below 12g/dL at baseline.
Full Information
NCT ID
NCT05620355
First Posted
November 10, 2022
Last Updated
March 19, 2023
Sponsor
Bio Genuine (Shanghai) Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05620355
Brief Title
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Genuine (Shanghai) Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Heavy Menstrual Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BG2109 100mg group
Arm Type
Experimental
Arm Description
One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
Arm Title
BG2109 200mg+ABT group
Arm Type
Experimental
Arm Description
Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
Intervention Type
Drug
Intervention Name(s)
BG2109
Intervention Description
BG2109 100mg film coated tablet for oral administration once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo for BG2109
Intervention Description
Placebo for BG2109 100mg tablet for oral administration once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo for add-back therapy
Intervention Description
Placebo for add-back therapy tablet for oral administration once daily.
Intervention Type
Drug
Intervention Name(s)
Add-back therapy
Intervention Description
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Primary Outcome Measure Information:
Title
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24.
Description
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.
Time Frame
The last 28 days before the Week 24.
Secondary Outcome Measure Information:
Title
Time to reduced MBL before the Week 24.
Description
Reduced MBL means MBL less than 80ml and more than 50% reduction in MBL compared to the baseline.
Time Frame
From baseline to Week 24.
Title
Percentage of amenorrhea at the Week 24.
Description
Amenorrhea is defined as having 0 data (or volume below the lower limit of quantification) from the AHM of MBL from the central laboratory or missing of AHM data with reported of "spotting" or "no bleeding" in the eDiary for 35 days before Week 24.
Time Frame
From baseline to Week 24.
Title
Time to amenorrhea before the Week 24.
Description
The number of days from Study Day 1 to the first day having amenorrhea.
Time Frame
From baseline to Week 24.
Title
Days of menstrual bleeding in the last 28 days before the Week 24.
Description
Record the number of days.
Time Frame
The last 28 days before the Week 24.
Title
Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
Description
Anemia is defined as hemoglobin below 12g/dL at baseline.
Time Frame
The Week 24.
Other Pre-specified Outcome Measures:
Title
Percentage of Responders at the Week 52.
Description
Responder is defined as above.
Time Frame
The last 28 days before the Week 52.
Title
Time to reduced MBL before the Week 52.
Description
Reduced MBL is defined as above.
Time Frame
From baseline to Week 52.
Title
Percentage of amenorrhea at the Week 52.
Description
Amenorrhea is defined as above.
Time Frame
From baseline to Week 52.
Title
Time to amenorrhea before the Week 52.
Description
The number of days from Study Day 1 to the first day having amenorrhea.
Time Frame
From baseline to Week 52.
Title
By 52 weeks, the number of days with menstrual bleeding per 28 days.
Description
Record the number every 28days.
Time Frame
From baseline to Week 52.
Title
Score of Uterine Fibroids related pain, symptoms and quality of life.
Description
Use specified scales.
Time Frame
From Week 12 to Week 64
Title
Bone Mineral Density (BMD)
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time Frame
The Week 24 and Week 52.
Title
Adverse events
Description
Clinical manifestation，frequency and severity of Treatment-Emergent Adverse Events.
Time Frame
Up to Week 64.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Chen
Phone
021-58590032
Email
Lisa.Chen@Bio-Genuine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Congjian Xu
Organizational Affiliation
Obstetrics & Gynecology Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site no.28
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.31
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.34
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.11
City
Changchun
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.6
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.7
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.17
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.22
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.10
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.3
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.4
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.19
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Site no.21
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Name
Site no.23
City
Lianyungang
Country
China
Individual Site Status
Recruiting
Facility Name
Site no.14
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.15
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.16
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.26
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.18
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.1
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Site no.29
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Site no.8
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.30
City
Shenzhen
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.5
City
Taiyuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.2
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.20
City
Wenzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.25
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.13
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Site no.32
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
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