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

BioGenuine

Status and phase: Enrolling; Phase 3

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Treatments: Drug: Add-back therapy; Drug: Placebo for BG2109; Drug: BG2109; Drug: Placebo for add-back therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05620355

BG2109-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 312 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 3 patient groups, including a placebo group

BG2109 100mg group

Experimental group

Description:

One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.

Treatment:

Drug: BG2109

Drug: Placebo for BG2109

Drug: Placebo for add-back therapy

BG2109 200mg+ABT group

Experimental group

Description:

Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.

Treatment:

Drug: BG2109

Drug: Add-back therapy

Placebo group

Placebo Comparator group

Description:

Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.

Treatment:

Drug: Placebo for BG2109

Drug: Placebo for add-back therapy