NCT05620355

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Uterine Fibroids
• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	BG2109	BG2109 100mg film coated tablet for oral administration once daily.
DRUG	Placebo for BG2109	Placebo for BG2109 100mg tablet for oral administration once daily.
DRUG	Placebo for add-back therapy	Placebo for add-back therapy tablet for oral administration once daily.
DRUG	Add-back therapy	Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.

Timeline

• Start date: 2022-12-16
• Primary completion: 2024-05-01
• Completion: 2025-03-01
• First posted: 2022-11-17
• Last updated: 2023-03-21

Locations

29 sites across 1 country: China