Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials.

ABSTRACT:

Objective

To investigate the efficacy of elagolix plus add-back therapy (estradiol [1 mg] and norethindrone acetate [0.5 mg] once daily) on patient-reported nonbleeding symptoms and menstrual bleeding associated with uterine fibroids (UFs) across different subpopulations.

Design

Post hoc analysis of two phase 3 clinical trials-Elaris UF-1 and UF-2.

Setting

A total of 76 (UF-1) and 77 (UF-2) US clinical sites.

Patients

Women (N = 591) with UFs and heavy menstrual bleeding.

Interventions

Elagolix (300 mg) twice daily with add-back therapy (the indicated dose for UF-associated heavy menstrual bleeding) vs. placebo for 6 months.

Main outcome measures

"Very much improved" or "much improved" change in nonbleeding symptoms (abdominal/pelvic pain, abdomin

SUBMITTER: Simon JA 

PROVIDER: S-EPMC11456625 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature