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

March 19, 2023 updated by: Bio Genuine (Shanghai) Biotech Co., Ltd.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Site no.28
      • Beijing, China
        • Not yet recruiting
        • Site no.31
      • Beijing, China
        • Not yet recruiting
        • Site no.34
      • Changchun, China
        • Not yet recruiting
        • Site no.11
      • Changsha, China
        • Not yet recruiting
        • Site no.6
      • Changsha, China
        • Not yet recruiting
        • Site no.7
      • Chengdu, China
        • Not yet recruiting
        • Site no.17
      • Chengdu, China
        • Not yet recruiting
        • Site no.22
      • Chongqing, China
        • Not yet recruiting
        • Site no.10
      • Guangzhou, China
        • Not yet recruiting
        • Site no.3
      • Guangzhou, China
        • Not yet recruiting
        • Site no.4
      • Hangzhou, China
        • Recruiting
        • Site no.19
      • Jinan, China
        • Recruiting
        • Site no.21
      • Lianyungang, China
        • Recruiting
        • Site no.23
      • Nanjing, China
        • Not yet recruiting
        • Site no.14
      • Nanjing, China
        • Not yet recruiting
        • Site no.15
      • Nanjing, China
        • Not yet recruiting
        • Site no.16
      • Nanjing, China
        • Not yet recruiting
        • Site no.26
      • Shanghai, China
        • Not yet recruiting
        • Site no.18
      • Shanghai, China
        • Recruiting
        • Site no.1
      • Shanghai, China
        • Recruiting
        • Site no.29
      • Shenyang, China
        • Not yet recruiting
        • Site no.8
      • Shenzhen, China
        • Not yet recruiting
        • Site no.30
      • Taiyuan, China
        • Not yet recruiting
        • Site no.5
      • Tianjin, China
        • Not yet recruiting
        • Site no.2
      • Wenzhou, China
        • Not yet recruiting
        • Site no.20
      • Wuhan, China
        • Not yet recruiting
        • Site no.25
      • Xi'an, China
        • Not yet recruiting
        • Site no.13
      • Zhengzhou, China
        • Not yet recruiting
        • Site no.32

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BG2109 100mg group
One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
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.
Experimental: BG2109 200mg+ABT group
Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
Drug: BG2109
BG2109 100mg film coated tablet for oral administration once daily.
Drug: Add-back therapy
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Placebo Comparator: Placebo group
Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24.
Time Frame: The last 28 days before the 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to reduced MBL before the Week 24.
Time Frame: From baseline to Week 24.
Reduced MBL means MBL less than 80ml and more than 50% reduction in MBL compared to the baseline.
From baseline to Week 24.
Percentage of amenorrhea at the Week 24.
Time Frame: From baseline to 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.
From baseline to Week 24.
Time to amenorrhea before the Week 24.
Time Frame: From baseline to Week 24.
The number of days from Study Day 1 to the first day having amenorrhea.
From baseline to Week 24.
Days of menstrual bleeding in the last 28 days before the Week 24.
Time Frame: The last 28 days before the Week 24.
Record the number of days.
The last 28 days before the Week 24.
Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
Time Frame: The Week 24.
Anemia is defined as hemoglobin below 12g/dL at baseline.
The Week 24.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Responders at the Week 52.
Time Frame: The last 28 days before the Week 52.
Responder is defined as above.
The last 28 days before the Week 52.
Time to reduced MBL before the Week 52.
Time Frame: From baseline to Week 52.
Reduced MBL is defined as above.
From baseline to Week 52.
Percentage of amenorrhea at the Week 52.
Time Frame: From baseline to Week 52.
Amenorrhea is defined as above.
From baseline to Week 52.
Time to amenorrhea before the Week 52.
Time Frame: From baseline to Week 52.
The number of days from Study Day 1 to the first day having amenorrhea.
From baseline to Week 52.
By 52 weeks, the number of days with menstrual bleeding per 28 days.
Time Frame: From baseline to Week 52.
Record the number every 28days.
From baseline to Week 52.
Score of Uterine Fibroids related pain, symptoms and quality of life.
Time Frame: From Week 12 to Week 64
Use specified scales.
From Week 12 to Week 64
Bone Mineral Density (BMD)
Time Frame: The Week 24 and Week 52.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
The Week 24 and Week 52.
Adverse events
Time Frame: Up to Week 64.
Clinical manifestation，frequency and severity of Treatment-Emergent Adverse Events.
Up to Week 64.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bio Genuine (Shanghai) Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Congjian Xu, Obstetrics & Gynecology Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BG2109-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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