Clinical trial NCT05620355: Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uterine Fibroids
Heavy Menstrual Bleeding
Lead sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 312
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24.
timeFrame: The last 28 days before the Week 24.
Secondary outcomes:
measure: Time to reduced MBL before the Week 24.
timeFrame: From baseline to Week 24.
measure: Percentage of amenorrhea at the Week 24.
timeFrame: From baseline to Week 24.
measure: Time to amenorrhea before the Week 24.
timeFrame: From baseline to Week 24.
measure: Days of menstrual bleeding in the last 28 days before the Week 24.
timeFrame: The last 28 days before the Week 24.
measure: Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.
timeFrame: The Week 24.
Other outcomes:
measure: Percentage of Responders at the Week 52.
timeFrame: The last 28 days before the Week 52.
measure: Time to reduced MBL before the Week 52.
timeFrame: From baseline to Week 52.
measure: Percentage of amenorrhea at the Week 52.
timeFrame: From baseline to Week 52.
measure: Time to amenorrhea before the Week 52.
timeFrame: From baseline to Week 52.
measure: By 52 weeks, the number of days with menstrual bleeding per 28 days.
timeFrame: From baseline to Week 52.
measure: Score of Uterine Fibroids related pain, symptoms and quality of life.
timeFrame: From Week 12 to Week 64
measure: Bone Mineral Density (BMD)
timeFrame: The Week 24 and Week 52.
measure: Adverse events
timeFrame: Up to Week 64.
Locations:
city: Beijing
country: China
facility: Site no.28
city: Beijing
country: China
facility: Site no.31
city: Beijing
country: China
facility: Site no.34
city: Changchun
country: China
facility: Site no.11
city: Changsha
country: China
facility: Site no.6
city: Changsha
country: China
facility: Site no.7
city: Chengdu
country: China
facility: Site no.17
city: Chengdu
country: China
facility: Site no.22
city: Chongqing
country: China
facility: Site no.10
city: Guangzhou
country: China
facility: Site no.3
city: Guangzhou
country: China
facility: Site no.4
city: Hangzhou
country: China
facility: Site no.19
city: Jinan
country: China
facility: Site no.21
city: Lianyungang
country: China
facility: Site no.23
city: Nanjing
country: China
facility: Site no.14
city: Nanjing
country: China
facility: Site no.15
city: Nanjing
country: China
facility: Site no.16
city: Nanjing
country: China
facility: Site no.26
city: Shanghai
country: China
facility: Site no.18
city: Shanghai
country: China
facility: Site no.1
city: Shanghai
country: China
facility: Site no.29
city: Shenyang
country: China
facility: Site no.8
city: Shenzhen
country: China
facility: Site no.30
city: Taiyuan
country: China
facility: Site no.5
city: Tianjin
country: China
facility: Site no.2
city: Wenzhou
country: China
facility: Site no.20
city: Wuhan
country: China
facility: Site no.25
city: Xi'an
country: China
facility: Site no.13
city: Zhengzhou
country: China
facility: Site no.32
Study officials:
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Congjian Xu
role: PRINCIPAL_INVESTIGATOR
References: