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

Uterine Fibroids Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620355
• Other study ID #: BG2109-301
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Leiomyoma
• Menorrhagia
• Uterine Fibroids

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.