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

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd.

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 each of the 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.