Related Experiment Video
Updated: Feb 4, 2026
Author Spotlight: Advancing Labor Management Through Electromyometrial Imaging for Understanding Uterine Contractions
Published on: May 26, 2023
Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized
Bruce R Carr1, Elizabeth A Stewart, David F Archer
1University of Texas Southwestern Medical Center, Dallas, Texas; the Mayo Clinic, Rochester, Minnesota; Eastern Virginia Medical School, Norfolk, Virginia; the University of Illinois at Chicago, Chicago, Illinois; Cleveland Clinic, Cleveland, Ohio; Mercy Health Osteoporosis and Bone Health Services, Cincinnati, Ohio; Augusta University, Augusta, Georgia; AbbVie Inc., North Chicago, Illinois; and George Washington University, Washington, DC.
Objective:
To evaluate elagolix, an oral gonadotropin-releasing hormone receptor antagonist, alone or with add-back therapy, in premenopausal women with heavy menstrual bleeding (greater than 80 mL per month) associated with uterine leiomyomas.
Methods:
This double-blind, randomized, placebo-controlled, parallel-group study evaluated efficacy and safety of elagolix in cohorts 1 (300 mg twice daily) and 2 (600 mg daily) with four arms per cohort: placebo, elagolix alone, elagolix with 0.5 mg estradiol/0.1 norethindrone acetate, and elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate. A sample size of 65 per group was planned to compare elagolix with add-back to placebo on the primary end point: the percentage of women who had less than 80 mL menstrual blood loss and 50% or greater reduction in menstrual blood loss from baseline to the last 28 days of treatment. Safety assessments included changes in bone mineral density.
Results:
From April 8, 2013, to December 8, 2015, 571 women were enrolled, 567 were randomized and treated (cohort 1=259; cohort 2=308), and 80% and 75% completed treatment, respectively. Participants had a mean±SD age of 43±5 years (cohort 2, 42±5 years), and 70% were black (cohort 2, 74%). Primary end point responder rates in cohort 1 (cohort 2) were 92% (90%) for elagolix alone, 85% (73%) for elagolix with 0.5 mg estradiol/0.1 mg norethindrone acetate, 79% (82%) for elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate, and 27% (32%) for placebo (all P<.001 vs placebo). Elagolix groups had significant decreases compared with placebo in lumbar spine bone mineral density, which was attenuated by adding 1.0 mg estradiol/0.5 mg norethindrone acetate.
Conclusion:
Elagolix with and without add-back significantly reduced menstrual blood loss in women with uterine leiomyomas. Add-back therapy reduced hypoestrogenic effects on bone mineral density.
Clinical Trial Registration:
ClinicalTrials.gov, NCT01817530; EU Clinical Trial Register, 2013-000082-37.
More Related Videos
Related Concept Videos
01:19The Menstrual Cycle
The menstrual phase occurs from days 1 to 5 and involves the shedding of the stratum functionalis, as a...
01:16Uterine Tubes
01:22Bleeding in Fresh Concrete
Bleeding can cause several issues in the concrete structure. Sometimes, the rising water gets trapped beneath large aggregate...
01:22Hormonal Regulation of the Menstrual Cycle
At puberty, GnRH begins a pulsatile release pattern, which triggers the anterior pituitary gland to secrete follicle-stimulating hormone (FSH) and luteinizing hormone (LH). The frequency and amplitude of GnRH pulses vary across the menstrual cycle, with faster pulses favoring LH release and slower pulses favoring FSH...
01:11Clinical Trials: Overview
01:12Trial and Error and Algorithm