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 treatmentTwo-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 values
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
2020
Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone–antagonist: a randomized clinical trial
Donnez J, Taylor HS, Taylor RN, Akin MD, Tatarchuk TF, Wilk K, Gotteland JP, Lecomte V, Bestel E. Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone–antagonist: a randomized clinical trial. Fertility And Sterility 2020, 114: 44-55. PMID: 32505383, DOI: 10.1016/j.fertnstert.2020.02.114.Peer-Reviewed Original ResearchConceptsEndometriosis-associated painBone mineral densityNon-menstrual pelvic painPelvic painDose-dependent fashionSerum estradiolOral gonadotropin-releasing hormone antagonistSevere endometriosis-associated painGonadotropin-releasing hormone antagonistOverall pelvic painRates of amenorrheaDose-ranging trialRandomized clinical trialsNumber of respondersPrimary endpointBMD lossTotal hipFemoral neckHormone antagonistClinical centersParallel groupClinical trialsMineral densityLife measuresMAIN OUTCOME
2019
The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?
Miller VM, Naftolin F, Asthana S, Black DM, Brinton EA, Budoff MJ, Cedars MI, Dowling NM, Gleason CE, Hodis HN, Jayachandran M, Kantarci K, Lobo RA, Manson JE, Pal L, Santoro NF, Taylor HS, Harman SM. The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned? Menopause The Journal Of The North American Menopause Society 2019, 26: 1071-1084. PMID: 31453973, PMCID: PMC6738629, DOI: 10.1097/gme.0000000000001326.Peer-Reviewed Original ResearchConceptsKronos Early Estrogen Prevention StudyCarotid artery intima-media thicknessPostmenopausal womenPrevention StudyAncillary studiesO-CEEHealth initiativesArtery intima-media thicknessInitiation of HTPlacebo-controlled trialCoronary artery calciumEffect of menopauseWomen's Health InitiativeIntima-media thicknessProgression of atherosclerosisAge of menopauseBone mineral densitySevere adverse effectsWhite matter hyperintensitiesVariants of genesMenopausal hormonesBreast painArtery calciumUse of HTVenous thrombosis
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 outcomesLong-Term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-Associated Pain [11OP]
Surrey E, Taylor H, Duan W, Peloso P, Schwefel B, Chwalisz K. Long-Term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-Associated Pain [11OP]. Obstetrics And Gynecology 2018, 131: 4s. DOI: 10.1097/01.aog.0000533299.54528.7c.Peer-Reviewed Original ResearchNon-menstrual pelvic painEndometriosis-associated painBone mineral densityAdverse eventsPivotal studiesElagolix treatmentLumbar spine BMD Z-scoreExtension studyNon-peptide GnRH antagonistsSevere endometriosis-associated painSpine BMD Z-scoreEfficacy of elagolixCommon adverse eventsPhase 3 studyBMD Z-scoresNew safety concernsLong-term safetyDose-dependent decreaseDyspareunia scoresEndometrial thicknessPelvic painHot flushesGnRH antagonistDose groupMineral density
2017
Cross-sex testosterone therapy in ovariectomized mice: addition of low-dose estrogen preserves bone architecture
Goetz TG, Mamillapalli R, Devlin MJ, Robbins AE, Majidi-Zolbin M, Taylor HS. Cross-sex testosterone therapy in ovariectomized mice: addition of low-dose estrogen preserves bone architecture. AJP Endocrinology And Metabolism 2017, 313: e540-e551. PMID: 28765273, PMCID: PMC5792142, DOI: 10.1152/ajpendo.00161.2017.Peer-Reviewed Original ResearchConceptsDual-energy X-ray absorptiometryBone mineral densityCross-sex hormone therapySpine bone mineral densityHormone therapyBone volume fractionBone acquisitionEstrogen treatmentTrabecular numberTrabecular separationComparable bone mineral densityLow-dose estrogen treatmentCortical area fractionPotential future clinical implicationsBone architectureEffects of testosteroneX-ray absorptiometryFuture clinical implicationsTestosterone therapyBone healthEstrogen lossOvariectomized miceTestosterone groupEstrogen deficiencyVehicle injectionTreatment 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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