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

Phase 3UnknownNCT05620355

Bio Genuine (Shanghai) Biotech Co., Ltd.312 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

312

Conditions

Uterine Fibroids Heavy Menstrual Bleeding

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (29)

Site no.28

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: The last 28 days before the Week 24.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From baseline to Week 24.

Days of menstrual bleeding in the last 28 days before the Week 24.

Record the number of days.

Time frame: 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.

Time frame: The Week 24.

Central Contacts

Lisa Chen

CONTACT

021-58590032 Lisa.Chen@Bio-Genuine.com

Data from ClinicalTrials.gov

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