Bone mineral density with elagolix plus add-back therapy in women with heavy menstrual bleeding and uterine fibroids: open-label and post-treatment results of a 60-month phase 3 trial.

ABSTRACT:

Background

The gonadotropin-releasing hormone antagonist elagolix (ELA) plus hormonal add-back (+AB) therapy reduces menstrual blood loss in women with heavy menstrual bleeding (HMB) associated and uterine fibroids. Prescribed ELA+AB therapy is limited to 24 months due to concerns about the hypoestrogenic effects of potential decreased bone mineral density (BMD).

Objectives

To evaluate 48-month safety and BMD effects of ELA+AB therapy in premenopausal women with HMB associated with uterine fibroids.

Study design

This phase 3b, multicenter study (NCT03271489) was conducted September 13, 2017-June 28, 2024. Three study periods included a 12-month randomized, double-blind treatment period (months 1-12), a 36-month open-label extension (OLE) period (months 13-48), and a 1

SUBMITTER: Schnell VL 

PROVIDER: S-EPMC12657715 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature