{"id":"https://openalex.org/W4416724969","doi":"https://doi.org/10.1002/rmb2.12700","title":"Relugolix Combination Tablets in Healthy Japanese Premenopausal Women: Pharmacokinetics, Pharmacodynamics, and Safety Profile","display_name":"Relugolix Combination Tablets in Healthy Japanese Premenopausal Women: Pharmacokinetics, Pharmacodynamics, and Safety Profile","publication_year":2025,"publication_date":"2025-01-01","ids":{"openalex":"https://openalex.org/W4416724969","doi":"https://doi.org/10.1002/rmb2.12700","pmid":"https://pubmed.ncbi.nlm.nih.gov/41321410","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/12657618"},"language":"en","primary_location":{"id":"doi:10.1002/rmb2.12700","doi":"https://doi.org/10.1002/rmb2.12700","is_oa":true,"landing_page_url":"https://doi.org/10.1002/rmb2.12700","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/rmb2.12700","source":{"id":"https://openalex.org/S86486980","display_name":"Reproductive Medicine and Biology","issn_l":"1445-5781","issn":["1445-5781","1447-0578"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","jufo-1","ki-jl-1","norway-1","oarl","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Reproductive Medicine and Biology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/rmb2.12700","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5035399792","display_name":"Yutaka Osuga","orcid":"https://orcid.org/0000-0002-6660-1066","observed_orcids":["https://orcid.org/0000-0002-6660-1066"]},"institutions":[{"id":"https://openalex.org/I74801974","display_name":"The University of Tokyo","ror":"https://ror.org/057zh3y96","country_code":"JP","type":"education","lineage":["https://openalex.org/I74801974"]},{"id":"https://openalex.org/I87531838","display_name":"Teikyo University","ror":"https://ror.org/01gaw2478","country_code":"JP","type":"education","lineage":["https://openalex.org/I87531838"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Yutaka Osuga","raw_affiliation_strings":["Obstetrics and Gynecology, Graduate School of Medicine The University of Tokyo  Tokyo Japan","Teikyo Academic Research Center Teikyo University  Tokyo Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Obstetrics and Gynecology, Graduate School of Medicine The University of Tokyo  Tokyo Japan","institution_ids":["https://openalex.org/I74801974"]},{"raw_affiliation_string":"Teikyo Academic Research Center Teikyo University  Tokyo Japan","institution_ids":["https://openalex.org/I87531838"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5027080978","display_name":"Hiroyasu Hozumi","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210090259","display_name":"ASKA Pharmaceutical (Japan)","ror":"https://ror.org/0097kbr85","country_code":"JP","type":"company","lineage":["https://openalex.org/I4210090259"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Hiroyasu Hozumi","raw_affiliation_strings":["Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan","institution_ids":["https://openalex.org/I4210090259"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000689407","display_name":"Masaki Fujisawa","orcid":"https://orcid.org/0009-0008-7696-7011","observed_orcids":["https://orcid.org/0009-0008-7696-7011"]},"institutions":[{"id":"https://openalex.org/I4210090259","display_name":"ASKA Pharmaceutical (Japan)","ror":"https://ror.org/0097kbr85","country_code":"JP","type":"company","lineage":["https://openalex.org/I4210090259"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Masaki Fujisawa","raw_affiliation_strings":["Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan","institution_ids":["https://openalex.org/I4210090259"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5038399460","display_name":"Kazuhiro Shimomiya","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210090259","display_name":"ASKA Pharmaceutical (Japan)","ror":"https://ror.org/0097kbr85","country_code":"JP","type":"company","lineage":["https://openalex.org/I4210090259"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Kazuhiro Shimomiya","raw_affiliation_strings":["Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan","institution_ids":["https://openalex.org/I4210090259"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5034834438","display_name":"Rieko Azuma","orcid":"https://orcid.org/0009-0006-2406-1985","observed_orcids":["https://orcid.org/0009-0006-2406-1985"]},"institutions":[{"id":"https://openalex.org/I4210090259","display_name":"ASKA Pharmaceutical (Japan)","ror":"https://ror.org/0097kbr85","country_code":"JP","type":"company","lineage":["https://openalex.org/I4210090259"]}],"countries":["JP"],"is_corresponding":true,"raw_author_name":"Rieko Azuma","raw_affiliation_strings":["Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan"],"raw_orcid":"https://orcid.org/0009-0006-2406-1985","affiliations":[{"raw_affiliation_string":"Development Division ASKA Pharmaceutical Co., Ltd.  Tokyo Japan","institution_ids":["https://openalex.org/I4210090259"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5034834438"],"corresponding_institution_ids":["https://openalex.org/I4210090259"],"apc_list":{"value":1850,"currency":"USD","value_usd":1850},"apc_paid":{"value":1850,"currency":"USD","value_usd":1850},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"24","issue":"1","first_page":"e12700","last_page":"e12700"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10600","display_name":"Reproductive Health and Contraception","score":0.600600004196167,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10600","display_name":"Reproductive Health and Contraception","score":0.600600004196167,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10960","display_name":"Hypothalamic control of reproductive hormones","score":0.07429999858140945,"subfield":{"id":"https://openalex.org/subfields/2743","display_name":"Reproductive Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10694","display_name":"Menopause: Health Impacts and Treatments","score":0.03319999948143959,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/relugolix","display_name":"relugolix","score":0.9169999957084656},{"id":"https://openalex.org/keywords/combination-tablets","display_name":"combination tablets","score":0.7609999775886536},{"id":"https://openalex.org/keywords/estradiol","display_name":"estradiol","score":0.9549999833106995},{"id":"https://openalex.org/keywords/norethisterone-acetate","display_name":"norethisterone acetate","score":0.9980000257492065},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.8320000171661377},{"id":"https://openalex.org/keywords/pharmacodynamics","display_name":"pharmacodynamics","score":0.9959999918937683},{"id":"https://openalex.org/keywords/premenopausal-women","display_name":"premenopausal women","score":0.9070000052452087},{"id":"https://openalex.org/keywords/japanese-women","display_name":"Japanese women","score":0.6150000095367432},{"id":"https://openalex.org/keywords/luteinizing-hormone","display_name":"luteinizing hormone","score":0.7960000038146973},{"id":"https://openalex.org/keywords/follicle-stimulating-hormone","display_name":"follicle-stimulating hormone","score":0.9980000257492065},{"id":"https://openalex.org/keywords/c-terminal-telopeptide-of-type-i-collagen","display_name":"C-terminal telopeptide of type I collagen","score":0.9049999713897705},{"id":"https://openalex.org/keywords/hot-flashes","display_name":"hot flashes","score":0.8820000290870667},{"id":"https://openalex.org/keywords/uterine-hemorrhage","display_name":"uterine bleeding","score":0.9980000257492065},{"id":"https://openalex.org/keywords/long-term-use","display_name":"long-term use","score":0.4699999988079071}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8274999856948853},{"id":"https://openalex.org/C3018359032","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Safety profile","level":3,"score":0.7663999795913696},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4496000111103058},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.35989999771118164},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.33169999718666077},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.3208000063896179},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.3190999925136566},{"id":"https://openalex.org/C194828623","wikidata":"https://www.wikidata.org/wiki/Q2861470","display_name":"Emergency medicine","level":1,"score":0.29829999804496765},{"id":"https://openalex.org/C29456083","wikidata":"https://www.wikidata.org/wiki/Q1221899","display_name":"Gynecology","level":1,"score":0.2944999933242798},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.25130000710487366}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1002/rmb2.12700","doi":"https://doi.org/10.1002/rmb2.12700","is_oa":true,"landing_page_url":"https://doi.org/10.1002/rmb2.12700","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/rmb2.12700","source":{"id":"https://openalex.org/S86486980","display_name":"Reproductive Medicine and Biology","issn_l":"1445-5781","issn":["1445-5781","1447-0578"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","jufo-1","ki-jl-1","norway-1","oarl","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Reproductive Medicine and Biology","raw_type":"journal-article"},{"id":"pmid:41321410","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/41321410","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Reproductive medicine and biology","raw_type":"Journal Article"},{"id":"pmh:oai:pubmedcentral.nih.gov:12657618","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12657618/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Reprod Med Biol","raw_type":"Text"},{"id":"pmh:oai:doaj.org/article:fc7decd019934d5c8f341c5ac30d90e8","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/fc7decd019934d5c8f341c5ac30d90e8","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Reproductive Medicine and Biology, Vol 24, Iss 1, Pp n/a-n/a (2025)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1002/rmb2.12700","doi":"https://doi.org/10.1002/rmb2.12700","is_oa":true,"landing_page_url":"https://doi.org/10.1002/rmb2.12700","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/rmb2.12700","source":{"id":"https://openalex.org/S86486980","display_name":"Reproductive Medicine and Biology","issn_l":"1445-5781","issn":["1445-5781","1447-0578"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-c","jufo-1","ki-jl-1","norway-1","oarl","poland-20","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Reproductive Medicine and Biology","raw_type":"journal-article"},"sustainable_development_goals":[{"score":1.0,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/randomized-controlled-trial","display_name":"Randomized Controlled Trial"},{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4416724969.pdf","grobid_xml":"https://content.openalex.org/works/W4416724969.grobid-xml"},"referenced_works_count":13,"referenced_works":["https://openalex.org/W1513717411","https://openalex.org/W1990060114","https://openalex.org/W2074049601","https://openalex.org/W2143755503","https://openalex.org/W2914196959","https://openalex.org/W2978453381","https://openalex.org/W3129366643","https://openalex.org/W4200280437","https://openalex.org/W4255664903","https://openalex.org/W4283034363","https://openalex.org/W4308775200","https://openalex.org/W4382046632","https://openalex.org/W4391051922"],"related_works":["https://openalex.org/W4382046632","https://openalex.org/W3199018729","https://openalex.org/W3092988807","https://openalex.org/W4395007814","https://openalex.org/W4365811145","https://openalex.org/W6939604617","https://openalex.org/W4391127097","https://openalex.org/W2148903238","https://openalex.org/W3207313530","https://openalex.org/W2048979809"],"abstract_inverted_index":{"Purpose:":[0],"To":[1],"evaluate":[2],"the":[3,40,76,120,145,152],"applicability":[4],"of":[5,8,45,49,141],"overseas-approved":[6],"dosage":[7],"relugolix":[9,50,54,87,146,153,173],"combination":[10,51,89,147,174,181],"tablets":[11,52,175,182],"(relugolix":[12,88],"40":[13],"mg,":[14,18],"estradiol":[15],"[E2]":[16],"1":[17],"and":[19,43,53,73,136,172,186],"norethisterone":[20],"acetate":[21],"0.5":[22],"mg)":[23,56],"in":[24,65,112,129,144,196],"healthy":[25],"premenopausal":[26],"Japanese":[27,197],"women.":[28],"Methods:":[29],"A":[30],"randomized,":[31],"double-blind":[32],"phase":[33],"I/II":[34],"study":[35],"was":[36,108,124],"conducted":[37],"to":[38,82,104],"compare":[39],"pharmacokinetics,":[41],"pharmacodynamics,":[42],"safety":[44,170,185],"repeated":[46],"once-daily":[47],"administration":[48],"(40":[55],"for":[57,86,193],"6":[58],"weeks.":[59],"Results:":[60],"There":[61,107,123,166],"were":[62,93,167,176],"26":[63],"participants":[64,157],"each":[66],"treatment":[67],"group.":[68],"The":[69,97,201],"mean":[70,98],"maximum":[71],"concentration":[72,135],"area":[74],"under":[75],"concentration-time":[77],"curve":[78],"from":[79,102,127],"time":[80],"zero":[81],"24":[83],"h":[84],"ratios":[85],"tablet":[90,148],"group/relugolix":[91],"group)":[92],"both":[94],"approximately":[95],"0.7-0.9.":[96],"E2":[99],"level":[100],"ranged":[101],"20":[103],"50":[105],"pg/mL.":[106],"no":[109,168],"notable":[110],"difference":[111],"luteinizing":[113],"hormone":[114,117],"or":[115,163],"follicle-stimulating":[116],"levels":[118],"between":[119],"two":[121],"groups.":[122],"less":[125],"change":[126],"baseline":[128],"type":[130],"I":[131],"collagen":[132],"C-terminal":[133],"telopeptide":[134],"a":[137],"lower":[138],"cumulative":[139],"incidence":[140],"hot":[142],"flashes":[143],"group":[149],"compared":[150],"with":[151],"group,":[154],"but":[155],"more":[156],"experienced":[158],"uterine":[159],"bleeding":[160],"(mostly":[161],"spotting":[162],"light":[164],"bleeding).":[165],"new":[169],"concerns":[171],"well":[177],"tolerated.":[178],"Conclusion:":[179],"Relugolix":[180],"have":[183],"favorable":[184],"efficacy":[187],"profiles,":[188],"potentially":[189],"making":[190],"them":[191],"suitable":[192],"long-term":[194],"use":[195],"patients.":[198],"Trial":[199],"Registration:":[200],"trial":[202],"registration":[203],"number":[204],"is":[205],"JapicRCT2071230042.":[206]},"counts_by_year":[],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2025-11-28T00:00:00"}
