James A Simon

Background: Elagolix (ELA) 200 mg twice daily is an oral treatment approved for moderate-to-severe endometriosis-associated pain. However, the clinical use of ELA is limited by potential hypoestrogenic effects, including the loss of bone mi…

BACKGROUND: Elagolix, an approved oral treatment for endometriosis-associated pain, has been associated with hypoestrogenic effects when used as monotherapy. Hormonal add-back therapy has the potential to mitigate these effects. OBJECTIVE:…

Bone mineral density (BMD) changes during the life span, increasing rapidly during adolescence, plateauing in the third decade of life, and subsequently entering a phase of age-related decline. In women, menopause leads to accelerated bone …

INTRODUCTION: Evaluate the efficacy of elagolix with add-back therapy on menstrual blood loss (MBL) and safety in women with uterine fibroids (UF), heavy menstrual bleeding (HMB) and adenomyosis. METHODS: Pooled data from two investigationa…

INTRODUCTION: Linzagolix is a new, non-peptide, GnRH receptor antagonist being developed to treat endometriosis-associated pain (EAP). The EDELWEISS trial is a Phase 2b, double-blind, randomized, placebo-controlled, multicenter, dose-rangin…

George Washington University School of Medicine, Women's Health & Research Consultants, Washington, DC Financial Disclosure Dr. Simon has served as a consultant/advisor to AbbVie, Allergan, AMAG Pharmaceuticals, ASCEND Therapeutics, Azure B…

OBJECTIVE: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. METHODS: Elaris Endometriosis (EM)-III and -IV were exten…

BACKGROUND: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppres…

Copyright © 2017 Massachusetts Medical Society. BACKGROUND Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, …

New therapies for abnormal uterine bleeding have been slow to reach the marketplace for a variety of reasons. These reasons include the availability of cost-effective therapies already available and the extraordinarily difficult and expensi…

Department of Obstetrics and Gynecology, George Washington University School of Medicine, Women's Health & Research Consultants®, Washington, DC Financial disclosure: Dr Simon has served as a consultant or on the advisory boards of Allergan…

Outley, Jackie K. PharmD, MBA; Gao, Cindy PhD; Simon, James A. MD; Spalding, James PharmD, MS; Botteman, Marc PhD Author Information

PURPOSE: The purpose of this study was to conduct a comprehensive and systematic literature review of the health-related quality of life (HRQL) burden of endometriosis in adults and adolescents. METHODS: We conducted a systematic search and…

Gao, Cindy PhD; Outley, Jackie K. PharmD, MBA; Botteman, Marc PhD; Spalding, James PharmD, MS; Simon, James A. MD; Pashos, Chris L. PhD Author Information

PURPOSE: To evaluate uterine changes on MRI before and after GnRH analog (GnRHa) treatment in diffuse adenomyosis. MATERIALS AND METHODS: Thirty-one patients with MRI features suggestive of diffuse adenomyosis received GnRHa for 6 months. D…