2025
Two-year follow-up study (PRIMROSE 3) to assess bone mineral density in subjects with uterine fibroids completing the PRIMROSE 1 and PRIMROSE 2 linzagolix trials
Donnez J, Petraglia F, Taylor H, Becker C, Becker S, Herrera F, Paszkowski M, Bestel E, Hori S, Dolmans M. Two-year follow-up study (PRIMROSE 3) to assess bone mineral density in subjects with uterine fibroids completing the PRIMROSE 1 and PRIMROSE 2 linzagolix trials. Human Reproduction Open 2025, 2025: hoaf025. PMID: 40575397, PMCID: PMC12202088, DOI: 10.1093/hropen/hoaf025.Peer-Reviewed Original ResearchDual-energy X-ray absorptiometryTotal hip bone mineral densityHip bone mineral densityBone mineral densityBaseline to monthAdd-back therapyLumbar spine bone mineral densitySpine bone mineral densityBone mineral density valuesAmerican Society of Reproductive MedicinePlacebo groupClinically relevant impactLumbar spineGedeon RichterOverall bone healthFemoral neckBaseline valuesTreatment groupsPrimary endpointSecondary endpointsL1-L4DEXA scanMineral densityFollow-up studyPre-treatment baseline valuesQuinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial
Pellicer A, Taylor H, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta K, Pinton P, Heiser P, Bagger Y. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. European Journal Of Obstetrics & Gynecology And Reproductive Biology 2025, 310: 113946. PMID: 40188683, DOI: 10.1016/j.ejogrb.2025.113946.Peer-Reviewed Original ResearchConceptsDeep infiltrating endometriosisVaginal ringNo significant differenceLesion sizeBleeding patternsMenstrual cycleSignificant differenceImaging biomarkersSerum prolactin levelsPhase 2 trialMenstrual bleeding patternsEndpoint of reductionPatient-reported outcomesHigh-resolution MRIInfiltrating endometriosisPlacebo groupDouble-blindPlacebo-ControlledAdvanced diseaseEndometriotic lesionsPrimary endpointPain reductionSecondary endpointsProlactin levelsAdverse events
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
Linzagolix 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 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
2020
Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix
Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstetrics And Gynecology 2020, 136: 501-509. PMID: 32769633, PMCID: PMC7431150, DOI: 10.1097/aog.0000000000003917.Peer-Reviewed Original ResearchConceptsResponder definitionPlacebo groupSevere painSexual intercourseEHP-30 questionnaireMeaningful HRQoL improvementsPercentage of patientsPhase III trialsHealth-related qualityPoisson regression analysisSocial supportHRQoL improvementIII trialsMonth 6Month 3EHP-30Months 1Baseline scoresElagolixPainPatientsMeaningful improvementsEndometriosisPlaceboRegression analysisHeart fat and carotid artery atherosclerosis progression in recently menopausal women: impact of menopausal hormone therapy: The KEEPS trial.
El Khoudary SR, Venugopal V, Manson JE, Brooks MM, Santoro N, Black DM, Harman M, Naftolin F, Hodis H, Brinton E, Miller V, Taylor H, Budoff M. Heart fat and carotid artery atherosclerosis progression in recently menopausal women: impact of menopausal hormone therapy: The KEEPS trial. Menopause The Journal Of The North American Menopause Society 2020, 27: 255-262. PMID: 32015261, PMCID: PMC7113029, DOI: 10.1097/gme.0000000000001472.Peer-Reviewed Original ResearchConceptsCarotid intima-media thicknessEpicardial adipose tissueProgression of atherosclerosisCIMT progressionHormone therapyAtherosclerosis progressionMenopausal womenOral conjugated equine estrogenParacardial adipose tissue volumeMenopausal hormone therapyPlacebo-controlled trialConjugated equine estrogensFat depositionIntima-media thicknessMcg/dAdipose tissue volumeRoute of administrationPAT changesCEE administrationPlacebo groupEquine estrogensT-E2Fat accumulationMonth progressionO-CEE
2019
Impact of menopausal hormone formulations on pituitary-ovarian regulatory feedback
Kling JM, Dowling NM, Bimonte-Nelson HA, Gleason CE, Kantarci K, Manson JE, Taylor HS, Brinton EA, Lobo RA, Cedars MI, Pal L, Neal-Perry G, Naftolin F, Harman SM, Miller VM. Impact of menopausal hormone formulations on pituitary-ovarian regulatory feedback. AJP Regulatory Integrative And Comparative Physiology 2019, 317: r912-r920. PMID: 31663769, PMCID: PMC6957372, DOI: 10.1152/ajpregu.00234.2019.Peer-Reviewed Original ResearchConceptsFollicle-stimulating hormoneKronos Early Estrogen Prevention StudyHormone levelsHormone therapyT-E2Menopausal womenTreatment groupsOral conjugated equine estrogenCommon hormone therapiesPituitary-ovarian hormonesPostmenopausal hormone therapyActive treatment groupConjugated equine estrogensMo of treatmentDouble-blinded treatmentPlacebo groupEquine estrogensMenopausal transitionPrevention StudyO-CEEHormonal modulationBaseline levelsCognitive declinePlaceboHormone formulations
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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