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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Uterine Fibroids, Heavy Menstrual Bleeding

Intervention / Treatment
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* Drug: BG2109
* Drug: Placebo for BG2109
* Drug: Placebo for add-back therapy
* Drug: Add-back therapy


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject is an 18 years and older premenopausal woman. Subject's Body Mass Index ≥ 18 kg/m2. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound. Subject's menstrual cycles is between 21 days and 35 days in the last 3 months. Subject has clinical manifestations of heavy menstrual bleeding. Subject's menstrual blood loss >80mL for at least 2 menstrual periods assessed at screening using the alkaline hematin method. Key Exclusion Criteria: The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study. The subject has a history of uterus surgery that would interfere with the study. The subject's condition is so severe that she will require surgery within 6 months. The subject have had or are currently suffering from any estrogen- dependent malignancy. The subject has a significant risk of osteoporosis, or have a known history of osteoporosis or other metabolic bone disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BG2109 100mg group<br>One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily. | Drug: BG2109<br>* BG2109 100mg film coated tablet for oral administration once daily.<br>Drug: Placebo for BG2109<br>* Placebo for BG2109 100mg tablet for oral administration once daily.<br>Drug: Placebo for add-back therapy<br>* Placebo for add-back therapy tablet for oral administration once daily.<br>|
| Experimental: BG2109 200mg+ABT group<br>Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily. | Drug: BG2109<br>* BG2109 100mg film coated tablet for oral administration once daily.<br>Drug: Add-back therapy<br>* Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.<br>|
| Placebo Comparator: Placebo group<br>Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily. | Drug: Placebo for BG2109<br>* Placebo for BG2109 100mg tablet for oral administration once daily.<br>Drug: Placebo for add-back therapy<br>* Placebo for add-back therapy tablet for oral administration once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |