Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.

ABSTRACT:

Objective

To determine if coexisting adenomyosis limits the efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy in reducing heavy menstrual bleeding in women with uterine fibroids.

Design

Pooled analysis of two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids [UF]-1 and UF-2).

Setting

A total of 153 gynecological clinical care settings in the United States and Canada.

Patients

Premenopausal women (18-51 years) with >80 mL of menstrual blood loss (MBL)/cycle and uterine fibroids with and without coexisting adenomyosis diagnosed by ultrasound and/or magnetic resonance imaging at baseline.

Interventions

Participants were randomized 1:1:2 to placebo, e

SUBMITTER: Muneyyirci-Delale O 

PROVIDER: S-EPMC8441572 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature