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Clinical trial

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.

NCT05620355 is registered in ClinicalTrials.gov with Bio Genuine (Shanghai) Biotech Co., Ltd. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Bio Genuine (Shanghai) Biotech Co., Ltd.
Phase
Phase 3
Overall status
Unknown status
Start date
December 16, 2022
Completion date
March 31, 2025
Enrollment
312 (estimated)
Sites
29

Conditions

As the registry lists them; a condition with its own page is linked.

heavy menstrual bleeding, uterine fibroids