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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620355
Other study ID # BG2109-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 16, 2022
Est. completion date March 2025

Study information

Verified date March 2023
Source Bio Genuine (Shanghai) Biotech Co., Ltd.
Contact Lisa Chen
Phone 021-58590032
Email Lisa.Chen@Bio-Genuine.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 312
Est. completion date March 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
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.

Locations

Country Name City State
China 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.1 Shanghai
China Site no.18 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

Sponsors (1)

Lead Sponsor Collaborator
Bio Genuine (Shanghai) Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of Responders at the Week 52. Responder is defined as above. The last 28 days before the Week 52.
Other Time to reduced MBL before the Week 52. Reduced MBL is defined as above. From baseline to Week 52.
Other Percentage of amenorrhea at the Week 52. Amenorrhea is defined as above. From baseline to Week 52.
Other Time to amenorrhea before the Week 52. The number of days from Study Day 1 to the first day having amenorrhea. From baseline to Week 52.
Other By 52 weeks, the number of days with menstrual bleeding per 28 days. Record the number every 28days. From baseline to Week 52.
Other Score of Uterine Fibroids related pain, symptoms and quality of life. Use specified scales. From Week 12 to Week 64
Other Bone Mineral Density (BMD) Assessed by dual-energy X-ray absorptiometry (DXA) scan. The Week 24 and Week 52.
Other Adverse events Clinical manifestation,frequency and severity of Treatment-Emergent Adverse Events. Up to Week 64.
Primary 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 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. From baseline to Week 24.
Secondary 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. From baseline to Week 24.
Secondary Time to amenorrhea before the Week 24. The number of days from Study Day 1 to the first day having amenorrhea. From baseline to Week 24.
Secondary Days of menstrual bleeding in the last 28 days before the Week 24. Record the number of days. The last 28 days before the Week 24.
Secondary Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia. Anemia is defined as hemoglobin below 12g/dL at baseline. The Week 24.
See also
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