Author Interviews, Endocrinology, OBGYNE, Pharmacology / 19.10.2016
GnRH Receptor Antagonist Elagolix Offers Hope for Patients With Endometriosis
MedicalResearch.com Interview with:
Hugh S. Taylor, MD
Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics
Gynecology, and Reproductive Sciences, Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The abstract presented at ASRM featured results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. Elagolix is an investigational, orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.
The data demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of Elagolix was consistent across both Phase 3 trials and also consistent with prior Elagolix studies.
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