Uterine FibroidsPhase 3NCT05620355
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
A Phase 3 study testing BG2109 and Add-back therapy in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by Bio Genuine (Shanghai) Biotech Co., Ltd. at 29 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids, Heavy Menstrual Bleeding
- What is being tested?
- BG2109 and Add-back therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 29 sitesChina
- Study dates
- 16 Dec 2022to Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites, 29 recruiting
- Not yet recruiting
Site no.28
Beijing
- Not yet recruiting
Site no.31
Beijing
- Not yet recruiting
Site no.34
Beijing
- Not yet recruiting
Site no.11
Changchun
- Not yet recruiting
Site no.6
Changsha
- Not yet recruiting
Site no.7
Changsha
- Not yet recruiting
Site no.17
Chengdu
- Not yet recruiting
Site no.22
Chengdu
- Not yet recruiting
Site no.10
Chongqing
- Not yet recruiting
Site no.3
Guangzhou
- Not yet recruiting
Site no.4
Guangzhou
- Recruiting
Site no.19
Hangzhou
- Recruiting
Site no.21
Jinan
- Recruiting
Site no.23
Lianyungang
- Not yet recruiting
Site no.14
Nanjing
- Not yet recruiting
Site no.15
Nanjing
- Not yet recruiting
Site no.16
Nanjing
- Not yet recruiting
Site no.26
Nanjing
- Not yet recruiting
Site no.18
Shanghai
- Recruiting
Site no.1
Shanghai
- Recruiting
Site no.29
Shanghai
- Not yet recruiting
Site no.8
Shenyang
- Not yet recruiting
Site no.30
Shenzhen
- Not yet recruiting
Site no.5
Taiyuan
- Not yet recruiting
Site no.2
Tianjin
- Not yet recruiting
Site no.20
Wenzhou
- Not yet recruiting
Site no.25
Wuhan
- Not yet recruiting
Site no.13
Xi'an
- Not yet recruiting
Site no.32
Zhengzhou
About this study
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.
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.
Read the 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.
- Conditions
- Uterine Fibroids, Heavy Menstrual Bleeding
- Being tested
- BG2109, Placebo for BG2109, Placebo for add-back therapy, Add-back therapy
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG2109Drug
BG2109 100mg film coated tablet for oral administration once daily.
Placebo for BG2109Drug
Placebo for BG2109 100mg tablet for oral administration once daily.
Placebo for add-back therapyDrug
Placebo for add-back therapy tablet for oral administration once daily.
Add-back therapyDrug
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
| Study group | Role | What they receive |
|---|---|---|
| BG2109 100mg group | Experimental | One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily. Receives: Drug: BG2109; Drug: Placebo for BG2109; Drug: Placebo for add-back therapy |
| BG2109 200mg+ABT group | Experimental | Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily. Receives: Drug: BG2109; Drug: Add-back therapy |
| Placebo group | Placebo comparator | Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily. Receives: Drug: Placebo for BG2109; Drug: Placebo for add-back therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The last 28 days before the Week 24.
Secondary outcomes (5)
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.
Measured: From baseline to Week 24.
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.
Measured: From baseline to Week 24.
Time to amenorrhea before the Week 24.
The number of days from Study Day 1 to the first day having amenorrhea.
Measured: From baseline to Week 24.
Days of menstrual bleeding in the last 28 days before the Week 24.
Record the number of days.
Measured: The last 28 days before the Week 24.
Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
Anemia is defined as hemoglobin below 12g/dL at baseline.
Measured: The Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start16 Dec 2022
- Primary completionMay 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Congjian Xu, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620355
- Sponsor's protocol ID
- BG2109-301
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05620355
- Acronym / sponsor ID
- BG2109-301
- Conditions
- Uterine Fibroids, Heavy Menstrual Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BG2109 100mg group | Experimental | Drug: BG2109, Drug: Placebo for BG2109, Drug: Placebo for add-back therapyOne 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 | Experimental | Drug: BG2109, Drug: Add-back therapyTwo tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily. |
| Placebo group | Placebo comparator | Drug: Placebo for BG2109, Drug: Placebo for add-back therapyTwo tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG2109BG2109 100mg film coated tablet for oral administration once daily. | Drug | BG2109 100mg group, BG2109 200mg+ABT group |
| Placebo for BG2109Placebo for BG2109 100mg tablet for oral administration once daily. | Drug | BG2109 100mg group, Placebo group |
| Placebo for add-back therapyPlacebo for add-back therapy tablet for oral administration once daily. | Drug | BG2109 100mg group, Placebo group |
| Add-back therapyEstradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily. | Drug | BG2109 200mg+ABT group |
Primary outcome
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.
5 secondary outcomes
Time to reduced MBL before the Week 24.
Time frame: From baseline to Week 24.
Percentage of amenorrhea at the Week 24.
Time frame: From baseline to Week 24.
Time to amenorrhea before the Week 24.
Time frame: 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.
Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
Time frame: The Week 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Congjian Xu principal investigator
Obstetrics & Gynecology Hospital of Fudan University
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BG2109 and Add-back therapy in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by Bio Genuine (Shanghai) Biotech Co., Ltd. at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Chen (021-58590032, Lisa.Chen@Bio-Genuine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24. (time frame: The last 28 days before the Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.