2022
O-306 LINZAGOLIX FOR ENDOMETRIOSIS-ASSOCIATED PAIN: SAFETY RESULTS FROM EDELWEISS 3, A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Donnez J, Taylor H, Gemzell-Danielsson K, Catherino W, Bestel E, Gotteland J, Humberstone A, Moore L, Garner E. O-306 LINZAGOLIX FOR ENDOMETRIOSIS-ASSOCIATED PAIN: SAFETY RESULTS FROM EDELWEISS 3, A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL. Human Reproduction 2022, 37: deac105.103. DOI: 10.1093/humrep/deac105.103.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsEndometriosis-associated painSevere endometriosis-associated painBone mineral densityMonths of treatmentSafety resultsPlacebo groupTreatment armsSerious treatment-emergent adverse eventsLumbar spine bone mineral densityZ-scoreLS bone mineral densityMulticenter phase 3 trialSpine bone mineral densityEmergent adverse eventsPhase 3 trialActive treatment armsReproductive-aged womenGnRH receptor antagonistTRIAL REGISTRATION NUMBERMean percent changePARTICIPANTS/MATERIALSROLE OF CHANCEDose-dependent mannerAdverse eventsPost-treatment Efficacy and Safety Follow-up in Women with Uterine Fibroids Treated for 52 Weeks With Linzagolix [A108]
Taylor H, Donnez J, Bestel E, Humberstone A, Garner E. Post-treatment Efficacy and Safety Follow-up in Women with Uterine Fibroids Treated for 52 Weeks With Linzagolix [A108]. Obstetrics And Gynecology 2022, 139: 31s-32s. DOI: 10.1097/01.aog.0000826752.16466.97.Peer-Reviewed Original ResearchBone mineral densityUterine fibroidsWeek 64Placebo-controlled phase 3 trialLumbar spine bone mineral densityTreatment of UFsSpine bone mineral densityHeavy menstrual bleedingPhase 3 trialWeeks of dosingHealth-related qualityCompletion of treatmentTreatment of womenEfficacy endpointPost-treatment efficacyTreatment discontinuationUterine bleedingWeek 52Key efficacyWeek 76Menstrual bleedingFibroid volumeMedian timeFollow-upMineral density
2017
Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. New England Journal Of Medicine 2017, 377: 28-40. PMID: 28525302, DOI: 10.1056/nejmoa1700089.Peer-Reviewed Original ResearchConceptsNonmenstrual pelvic painEndometriosis-associated painPelvic painClinical responsePercentage of womenPlacebo groupEnd pointPrimary efficacy end pointSevere endometriosis-associated painGonadotropin-releasing hormone antagonistOral GnRH antagonistRescue analgesic agentsEfficacy end pointPrimary end pointPhase 3 trialClinical response criteriaEstrogen-dependent conditionDaily electronic diaryBone mineral densityProportion of womenCorresponding percentagesEndometrial findingsEstrogen suppressionPain scoresHot flushes