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…

ObjectiveTo comprehensively review and evaluate the direct costs of endometriosis.Design and settingWe systematically reviewed studies published since 1990, and conducted an analysis of publicly available national databases (Healthcare Cost…

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

ObjectiveThe purpose of this study was to assess the in vitro effect of gonadotropin-releasing hormone agonist on natural killer cell activity in women with and without endometriosis and to ascertain whether gonadotropin-releasing hormone a…

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…

The persuasive data not only illustrate a familial tendency towards adenomyosis but also emphasize that adenomyosis can be diagnosed noninvasively and accurately by MRI. A possible familial predisposition toward or a direct familial cause o…