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

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.

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

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.