MedicalResearch.com Interview with: William D Schlaff  MD Chair, Department of Obstetrics & Gynecology Jefferson University MedicalResearch.com: What is the background for this study? Response: Symptomatic uterine fibroids are the most common indication for hysterectomy in the US.  Heavy bleeding is the most common and troublesome symptom.  The primary treatment for this problem is surgery—either hysterectomy or (less commonly) myomectomy.  Medical treatment which reduces the bleeding related to fibroids without surgery is a valuable treatment for many women.  Existing medications include, most commonly GnRH agonists.  These are injectable medications that are given every 1 or 3 months (depending on the formulation) and have been shown to reduce bleeding related to fibroids.  They work by initially stimulating the ovaries to increase estrogen levels for 10-14 days before suppressing estrogen and thereby reducing bleeding.  Even though the medication is given every 1 or 3 months, the effect of the medication can last quite a bit longer; in cases of adverse response, the medication cannot be immediately stopped.  The medication reported in this trial, Elagolix, is a GnRH antagonist given by mouth twice daily and resulting in suppression of estrogen secretion within a matter of hours.  The effect of this medication wears off much more rapidly than the depot formulations described and can be stopped in the uncommon cases of adverse side effects.  (more…)