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 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
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 injection
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