Thursday, January 23, 2020

Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids

Women with uterine fibroids who used elagolix with add-back therapy saw a reduction in heavy menstrual bleeding.

Abnormal bleeding is 1 of the most common indications of uterine fibroids and hysterectomy in the US, lead investigator William Schlaff, MD, a reproductive endocrinology and infertility physician at Jefferson University, told in an interview. The oral dose of elagolix with hormonal add-back therapy had a better effect than injectable medications.

Schlaff and colleagues from academic medical institutions across the US conducted 2 identical, double-blind, randomized, placebo-controlled, six-month phase 3 trials—Elaris uterine fibroids 1 (UF-1) and 2 (UF-2). The investigators evaluated the safety and efficacy of elagolix at a dose of 300 mg 2 times a day with hormonal add-back therapy in women with bleeding due to fibroids.

In roughly 70% of women, elagolix reduced abnormal bleeding, Schlaff said.

UF-1 and UF-2 each consisted of a 2.5–3.5 month screening period, a six-month treatment period, and a twelve-month follow-up period. The investigators randomly assigned the women to either receive a 300 mg dose of elagolix with add-back therapy twice a day, a 300 mg dose of elagolix alone twice daily, or placebo in a matched, double-blind, double-dummy manner.

The primary end point of the research was menstrual blood loss < 80 ml during the final month and at least a 50% reduction in menstrual blood loss form baseline to the last month. Some secondary end points included the change in menstrual blood loss from baseline to the end, the percentage of women who had suppression of bleeding at the end of the study, and the change from baseline in blood loss at 6 months.

Eligible women were premenopausal, between 18–51 years old at the time of screening, and had ultrasonography-confirmed uterine fibroids and heavy menstrual bleeding diagnoses.

Women reported their symptoms over the previous 4 weeks on the Uterine Fibroid Symptom and Quality of Life questionnaire. The questionnaire included a symptom severity score (0–100; higher scores indicated increased severity) and a health-related quality-of-life total score, which was the sum of scores on 6 subscales—concern, activities, energy and mood, control, self-consciousness, and sexual function. The scores ranged from 0–100, with higher scores associated with a better quality of life.

Source: HCP LIVE NETWORK



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