2025
Linzagolix with and without hormonal add-back therapy for symptomatic uterine fibroids: PRIMROSE 1 & 2 long-term extension and withdrawal study
Donnez J, Petraglia F, Taylor H, Becker C, Becker S, Herrera F, Bestel E, Hori S, Dolmans M. Linzagolix with and without hormonal add-back therapy for symptomatic uterine fibroids: PRIMROSE 1 & 2 long-term extension and withdrawal study. Fertility And Sterility 2025 PMID: 40543832, DOI: 10.1016/j.fertnstert.2025.06.016.Peer-Reviewed Original ResearchHormonal add-back therapyAdd-back therapyHeavy menstrual bleedingMenstrual blood lossSymptomatic uterine fibroidsCessation of therapyMenstrual bleedingBone mineral densityUterine fibroidsBlood lossWithdrawal studyMineral densityPlacebo-controlled phase 3 trialTreatment of symptomatic uterine fibroidsDecreased menstrual blood lossReducing menstrual blood lossRisk of bone lossReducing heavy menstrual bleedingExtension studySignificantly higher proportion of womenMonths of therapyFibroid-associated symptomsPhase 3 trialAlkaline haematin methodBenefits of treatment
2022
Linzagolix With and Without Hormonal Add-Back Therapy for the Treatment of Symptomatic Uterine Fibroids: Two Randomized, Placebo-Controlled, Phase 3 Trials
Donnez J, Taylor H, Stewart E, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland J, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix With and Without Hormonal Add-Back Therapy for the Treatment of Symptomatic Uterine Fibroids: Two Randomized, Placebo-Controlled, Phase 3 Trials. Obstetrical & Gynecological Survey 2022, 77: 741-742. DOI: 10.1097/ogx.0000000000001113.Peer-Reviewed Original ResearchLinzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials
Donnez J, Taylor HS, Stewart EA, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland JP, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials. The Lancet 2022, 400: 896-907. PMID: 36116480, DOI: 10.1016/s0140-6736(22)01475-1.Peer-Reviewed Original ResearchConceptsHeavy menstrual bleedingPhase 3 trialSymptomatic uterine fibroidsMenstrual bleedingUterine fibroidsTherapy groupPlacebo groupOral gonadotropin-releasing hormone receptor antagonistResponse rateGonadotropin-releasing hormone receptor antagonistCommon adverse eventsFull analysis setHormone receptor antagonistDose of treatmentMasked treatmentPrimary endpointStudy drugAdverse eventsEligible womenHot flushesChronic treatmentReceptor antagonistGonadal steroidsLinzagolixAnalysis setO-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 densityQuality 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 scoreIncidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix [A104]
Al-Hendy A, Taylor H, Catherino W, Stewart E, Bestel E, Garner E. Incidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix [A104]. Obstetrics And Gynecology 2022, 139: 30s-30s. DOI: 10.1097/01.aog.0000826736.08037.1b.Peer-Reviewed Original ResearchPhase 3 trialUterine fibroidsGnRH antagonistHair lossPlacebo-controlled phase 3 trialUterine fibroid-related symptomsFibroid-related symptomsIncidence of alopeciaOral GnRH antagonistPooled safety analysisTreatment of womenConcomitant therapyTreatment discontinuationStudy drugWeek 52Mild alopeciaWeek 24Benign disorderSimilar incidenceLinzagolixSuppression dosesAlopeciaFibroidsTrialsTreatment
2021
O-135 Long term secondary efficacy of linzagolix for heavy menstrual bleeding (HMB) due to uterine fibroids (UF): 52-week results from two placebo-controlled, randomized, phase 3 trials
Taylor H, Donnez J, Petraglia F, Danielsson K, Renner S, Bestel E, Gotteland J, Humberstone A, Garner E. O-135 Long term secondary efficacy of linzagolix for heavy menstrual bleeding (HMB) due to uterine fibroids (UF): 52-week results from two placebo-controlled, randomized, phase 3 trials. Human Reproduction 2021, 36: deab126.060. DOI: 10.1093/humrep/deab126.060.Peer-Reviewed Original ResearchHeavy menstrual bleedingQuality of lifePhase 3 trialWeeks of treatmentUterine fibroidsPain scoresSecondary endpointsMenstrual bleedingMean agePlacebo-controlled phase 3 trialPotential long-term treatmentOral GnRH antagonistSecondary efficacy assessmentsTrial subjectsTRIAL REGISTRATION NUMBERDifferent treatment regimensLong-term treatmentPARTICIPANTS/MATERIALSROLE OF CHANCEMaintenance of effectsSymptom recurrenceSecondary efficacySymptomatic improvementWeek 24Anemic patients
2018
Long-Term Outcomes of Elagolix in Women With Endometriosis
Surrey E, Taylor HS, Giudice L, Lessey BA, Abrao MS, Archer DF, Diamond MP, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Singh SS, Rechberger T, Agarwal SK, Duan WR, Schwefel B, Thomas JW, Peloso PM, Ng J, Soliman AM, Chwalisz K. Long-Term Outcomes of Elagolix in Women With Endometriosis. Obstetrics And Gynecology 2018, 132: 147-160. PMID: 29889764, DOI: 10.1097/aog.0000000000002675.Peer-Reviewed Original ResearchConceptsMonths of treatmentResponder rateAdverse eventsPlacebo-controlled phase 3 trialGonadotropin-releasing hormone antagonistBone mineral density assessmentCoprimary efficacy endpointsEndometriosis-associated painNonmenstrual pelvic painPelvic pain scoresSafety of elagolixCommon adverse eventsPhase 3 trialProportion of respondersNew safety concernsBone mineral densityClinical laboratory testsElagolix dosesElagolix treatmentEndometrial findingsEfficacy endpointPain scoresPelvic painHot flushesTerm outcomes
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
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