Elagolix shows promising results in the treatment of heavy menstrual bleeding associated with uterine fibroids

Oral elagolix either alone or with add-back therapy significantly reduces menstrual blood loss in 90% of pre-menopausal women with uterine fibroids reports the results of a new clinical trial published in November issue of Journal Obstetrics & Gynecology.

Elagolix is an oral gonadotropin-releasing hormone receptor antagonist and recently won FDA approval as the first and only oral drug for the management of severe pain associated with endometriosis.

This interventional, double-blind, randomized Phase 2b Study was conducted across five countries to evaluate the safety and efficacy of elagolix. Over a period of nearly 2.5 years, researchers enrolled 571 premenopausal women suffering from heavy menstrual blood loss and an ultrasound documented uterine fibroids.

These women were randomized to cohorts 1 (259) and 2 (308) and received 300 mg twice daily and 600 mg daily elgolix respectively. Each cohort has four arms: 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.

The primary outcome measure was the percentage of women with a Menstrual Blood Loss (MBL) volume of < 80 mL at the last 28 days of the treatment cycle and a ≥ 50% Reduction in MBL volume from baseline to the final month.  The primary safety concern was the change in bone mineral density.

The average age of the participant was 43±5 years, and 70% were black.  Women in both cohorts demonstrated a significant reduction in menstrual blood loss and reached the primary endpoint in all three arms (all P<.001 vs. placebo). 

Elagolix arm showed a significant decrease in lumbar spine bone mineral density as compared to placebo, but add-on therapy with 1.0 mg estradiol/0.5 mg norethindrone acetate stopped the bone loss.

Dr. Bruce Carr, Professor of Obstetrics and Gynecology at UT Southwestern Medical Center and lead author on the study said the oral therapy offers new hope for patients suffering from menorrhagia with uterine fibroids for whom hysterectomy or myomectomy was the gold standard treatment. 

 “There are no orally approved drugs to decrease bleeding and prevent anemia in women with these tumors. Now, there is a medical option for this devastating disease that affects up to 75 percent of women,” he further added in a new release by UT Southwestern Medical Center.

A phase 3 ELARIS UF-EXTEND study of elagolix has also shown parallel results as the phase 2b trial and ELARIS UF-I and ELARIS UF-II phase 3 studies. AbbVie plans to include the ELARIS UF-EXTEND data as part of a submission for regulatory approval of elagolix for the treatment of uterine fibroids in 2019.

Abstract

UTSouthwestern Medical Center news release

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