Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
NCT ID: NCT05620355
Last Updated: 2023-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
312 participants
INTERVENTIONAL
2022-12-16
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
BG2109
BG2109 100mg film coated tablet for oral administration once daily.
Placebo for BG2109
Placebo for BG2109 100mg tablet for oral administration once daily.
Placebo for add-back therapy
Placebo for add-back therapy tablet for oral administration once daily.
BG2109 200mg+ABT group
Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
BG2109
BG2109 100mg film coated tablet for oral administration once daily.
Add-back therapy
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Placebo group
Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
Placebo for BG2109
Placebo for BG2109 100mg tablet for oral administration once daily.
Placebo for add-back therapy
Placebo for add-back therapy tablet for oral administration once daily.
Interventions
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BG2109
BG2109 100mg film coated tablet for oral administration once daily.
Placebo for BG2109
Placebo for BG2109 100mg tablet for oral administration once daily.
Placebo for add-back therapy
Placebo for add-back therapy tablet for oral administration once daily.
Add-back therapy
Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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Bio Genuine (Shanghai) Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Congjian Xu
Role: PRINCIPAL_INVESTIGATOR
Obstetrics & Gynecology Hospital of Fudan University
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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BG2109-301
Identifier Type: -
Identifier Source: org_study_id
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