2024
Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3)
Donnez J, Becker C, Taylor H, Herrera F, Donnez O, Horne A, Paszkowski M, Petraglia F, Renner S, Patel A, Boolell M, Bestel E, Dolmans M. Linzagolix therapy versus a placebo in patients with endometriosis-associated pain: a prospective, randomized, double-blind, Phase 3 study (EDELWEISS 3). Human Reproduction 2024, 39: 1208-1221. PMID: 38648863, PMCID: PMC11144970, DOI: 10.1093/humrep/deae076.Peer-Reviewed Original ResearchNon-menstrual pelvic painAdd-back therapyEndometriosis-associated painPelvic painMonths of therapyPhase 3 studyGedeon RichterData monitoring boardDaily doseStatistically significant reductionPlacebo groupDouble-blindRoche DiagnosticsTreatment of endometriosis-associated painHormonal add-back therapyRates of hot flushesReduce dysmenorrheaGonadotropin-releasing hormone antagonistRisk of bone lossDATE OF FIRST PATIENT’S ENROLMENT:Overall pelvic painPublished phase 2Hypoestrogenic side effectsMonitoring boardCompared to placebo
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 eventsQuality of Life Improvements in Women with Uterine Fibroids: Results of Two Phase 3 Trials with Linzagolix [A107]
Al-Hendy A, Bradley L, Taylor H, Catherino W, Humberstone A, Garner E. Quality of Life Improvements in Women with Uterine Fibroids: Results of Two Phase 3 Trials with Linzagolix [A107]. Obstetrics And Gynecology 2022, 139: 31s-31s. DOI: 10.1097/01.aog.0000826748.26150.66.Peer-Reviewed Original ResearchPhase 3 trialUterine fibroidsPlacebo-controlled phase 3 trialTreatment of UFsFibroid-related symptomsHealth-related qualifyOral GnRH antagonistHealth-related qualityEnd of treatmentLong-term impairmentSubstantial beneficial effectPlacebo groupGnRH antagonistLife QuestionnaireSexual functionWeek 64Mean changeFrequent causeTreatment terminationEstradiol suppressionTreatment groupsLinzagolixPooled populationBeneficial effectsTotal score
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