[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-443302-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-443302-en":130},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","safety-of-48-months-of-elagolix-with-add-back-therapy-for-endometriosis-associated-pain","Safety of 48 months of elagolix with add-back therapy for endometriosis-associated pain","","Long-term safety results are provided from a 48-month phase 3 trial evaluating elagolix (ELA) plus hormonal add-back therapy (AB) in premenopausal women with moderate-to-severe endometriosis-associated pain. The study included a 12-month double-blind period, a 36-month open-label extension, and a 12-month post-treatment follow-up, with safety assessed throughout and bone mineral density measured by dual-energy X-ray absorptiometry. Treatment-emergent adverse events were generally mild to moderate and nonserious, and bone mineral density remained mostly stable through 48 months, with partial recovery in patients showing reduced BMD at final on-treatment visits.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/safety-of-48-months-of-elagolix-with-add-back-therapy-for-endometriosis-associated-pain/443302/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/safety-of-48-months-of-elagolix-with-add-back-therapy-for-endometriosis-associated-pain/443302.png","ImageObject",300,407,{"name":42,"@type":43},"Noah","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-03","2026-09-29",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",10,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What treatment was studied for endometriosis-associated pain?","Question",{"text":63,"@type":64},"The trial assessed elagolix (200 mg twice daily) with hormonal add-back therapy (estradiol/norethindrone acetate) versus an elagolix monotherapy sequence and placebo during the initial double-blind period. After the double-blind period, all patients received open-label elagolix plus add-back therapy.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"How was safety evaluated over the 48-month period?",{"text":68,"@type":64},"Safety was assessed throughout the open-label treatment period using treatment-emergent adverse events. The study reported that TEAEs were generally mild or moderate and nonserious.",{"name":70,"@type":61,"acceptedAnswer":71},"What happened to bone mineral density during continuous treatment?",{"text":72,"@type":64},"Bone mineral density remained generally stable over 48 months, with least squares mean percent decrease from baseline below 2% at all anatomical sites. For eligible patients with reduced BMD at final on-treatment visits, the majority showed partial or full recovery during the 12-month post-treatment follow-up.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},443302,1790739912,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,115,120,123,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":108,"slug":109},7,40,"healthcare",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":112,"show_sort_weight":113,"slug":114},8,"Research & Report",30,"research-report",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":118,"slug":119},9,"Religion & Spirituality",20,"religion-spirituality",{"id":118,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":118,"slug":122},"World Cup","world-cup",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":55,"slug":125},"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":97,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":107,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":55,"language":139,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":12,"update_tm":143,"read_time":144,"preview_page_count":4},8796095462418,"https://ap-avatar.wpscdn.com/avatar/80000253c1241d02b47?x-image-process=image/resize,m_fixed,w_180,h_180&k=1778826106357471780","Original Research AJOG Global Reports  \nSafety of 48 months of elagolix with add-back  therapy for endometriosis-associated pain  \nJin Hee Kim, MD; Charles E. Miller, MD; James A. Simon, MD; James W. Thomas, MS; Anna Chan, PharmD; Michael C. Snabes, MD, PhD  \n\n| | 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 mineral density (BMD) . The addition of hormonal add-back (AB) therapy (1-mg estradiol/0 .5-mg norethindrone acetate once daily) may attenuate BMD loss.\u003Cbr>OBJECTIVES: To provide long-term safety results from a 48-month phase 3 trial assessing ELA+AB therapy in premenopausal women with moderate-to-severe endometriosis-associated pain.\u003Cbr>STUDY DESIGN: This multicenter, phase 3 trial was conducted between July 7, 2017, and December 6, 2023, and included a 12-month doubleblind treatment period, a 36-month open-label extension period, and a 12-month post-treatment follow-up (PTFU) period. At the beginning of the doubleblind period, premenopausal women (aged 18􀀁49 years) with moderate-to-severe endometriosis-associated pain were randomized 4:1:2 to ELA+AB therapy, ELA monotherapy for 6 months followed by ELA+AB therapy for the remaining 6 months, or placebo. After the double-blind treatment period, all patients were treated with open-label ELA+AB therapy (referred to as the ELA+AB/ELA+AB, ELA/ELA+AB, and placebo/ELA+AB groups) for the remainder of the 36-month open-label treatment period. Safety was assessed throughout the open-label treatment period. BMD was measured by dualenergy X-ray absorptiometry in the lumbar spine, total hip, and femoral neck during the screening period and every 6 months throughout the study. BMD was analyzed using an analysis of covariance model with treatment as the main effect and baseline values as covariates.\u003Cbr>RESULTS: Among 380 patients who entered the open-label period, 140 (36 .8%) completed the treatment period, and 240 (63 .2%) discontinued, primarily due to withdrawn consent and adverse events (AEs) . In total, 159 (74 .0%) patients in the ELA+AB/ELA+AB group, 41 (69 .5%) patients in the ELA/ELA+AB group, and 80 (75.5%) patients in the placebo/ELA+AB group reported at least 1 treatment-emergent adverse event (TEAE) during the open-label period. TEAEs were generally mild or moderate and nonserious. The most commonly reported TEAEs were COVID- 19, bone density decreases, and sinusitis. No serious AEs were reported in >1 patient in any study group. BMD remained generally stable, with a least squares mean percent decrease from baseline to week 48 \u003C2% in all groups and at all anatomical sites. Similarly, the least squares mean decrease from baseline in BMD was \u003C2% in the ELA+AB/ELA+AB group at all anatomical sites and all time points throughout the study period. For patients in the ELA+AB/ELA+AB group with ≥48 months of treatment and reduced BMD at the final on-treatment visit, the majority (lumbar spine, 13 [59 . 1%]; total hip, 8 [53 .3%]; femoral neck, 12 [57 . 1%]) partially or fully recovered at month 12 of the PTFU period. CONCLUSIONS: This study extends findings from a previously reported 12-month analysis of the efficacy and safety of ELA+AB therapy in premenopausal women with moderate-to-severe endometriosis-associated pain. The safety profile of ELA+AB therapy was generally consistent with that observed in prior studies. BMD remained mostly stable through 48 months of continuous treatment. This analysis represents the longest safety study of ELA+AB therapy to date and supports long-term treatment with ELA+AB therapy.\u003Cbr>Key words: bone mineral density, elagolix, endometriosis, estradiol, pain, pelvic pain, safety | |\n| --- | --- | --- |\n\nFrom the Department of Obstetrics and Gynecology, Columbia University, New York, NY (Kim); Department of Minimally Invasive Gynecologic Surgery, Advocate Lutheran ","cbCaicm0KqtgrNPU","https://ap.wps.com/l/cbCaicm0KqtgrNPU","pdf",877647,"English","# Background\n# Objectives\n# Study Design\n# Results\n# Conclusions\n# Key Words","[{\"question\":\"What treatment was studied for endometriosis-associated pain?\",\"answer\":\"The trial assessed elagolix (200 mg twice daily) with hormonal add-back therapy (estradiol/norethindrone acetate) versus an elagolix monotherapy sequence and placebo during the initial double-blind period. After the double-blind period, all patients received open-label elagolix plus add-back therapy.\"},{\"question\":\"How was safety evaluated over the 48-month period?\",\"answer\":\"Safety was assessed throughout the open-label treatment period using treatment-emergent adverse events. The study reported that TEAEs were generally mild or moderate and nonserious.\"},{\"question\":\"What happened to bone mineral density during continuous treatment?\",\"answer\":\"Bone mineral density remained generally stable over 48 months, with least squares mean percent decrease from baseline below 2% at all anatomical sites. For eligible patients with reduced BMD at final on-treatment visits, the majority showed partial or full recovery during the 12-month post-treatment follow-up.\"}]","Safety of 48 months of elagolix with add-back therapy for endometriosis-associated pain | PDF",1790703563,25]