MedicalResearch.com Interview with:
Dr. James A. Simon, MD CCD, NCMP, FACOG
Clinical professor of obstetrics and gynecology
George Washington University, and
Medical director, Women's Health & Research Consultants®
Washington, D.C
MedicalResearch.com: What is the background for this study?
Response: The Phase 2b uterine fibroids study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) in women with heavy uterine bleeding associated with uterine fibroids. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.
The study was conducted in 567 premenopausal women, age 18 to 51, at 100 sites in the United States, Canada, Puerto Rico, Chile and the United Kingdom. The two cohort design study evaluated the safety and efficacy of two elagolix treatment regimens (300mg BID and 600mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). The data presented were results from the 300mg cohort. Results from the 600mg cohort were similar and will be reported in a future publication.
Current non-surgical treatments indicated for uterine fibroids are limited, and women suffering from heavy menstrual bleeding associated with uterine fibroids need more options.
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