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 treatmentEvaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene
Johnson J, Siblini H, Al‐Hendy A, Segars J, González F, Taylor H, Singh B, Carson S, Christman G, Huang H, Dangi B, Zhang H. Evaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene. Clinical And Translational Science 2025, 18: e70189. PMID: 40077973, PMCID: PMC11903501, DOI: 10.1111/cts.70189.Peer-Reviewed Original ResearchConceptsEpigallocatechin-3-gallateFolate levelsUterine fibroidsClinical trialsGreen tea extractAssociated with folate deficiencyPresence of MTHFRWomen of Childbearing AgeSerum folate levelsReduced folate levelsActive clinical trialsReproductive-age womenEffect of epigallocatechin gallateDHFR genotypeDHFR polymorphismTea extractDaily doseClomiphene citrateUnexplained infertilityFolate deficiencyChildbearing ageClinical studiesTreated womenFibroidsLetrozole
2024
Uterine fibroid–related infertility: mechanisms and management
Donnez J, Taylor H, Marcellin L, Dolmans M. Uterine fibroid–related infertility: mechanisms and management. Fertility And Sterility 2024, 122: 31-39. PMID: 38453041, DOI: 10.1016/j.fertnstert.2024.02.049.Peer-Reviewed Original ResearchUterine artery embolizationUterine fibroidsAssociation of fibroidsAdd-back therapyHeavy menstrual bleedingBaseline to weekOral GnRH antagonistPresence of fibroidsNon-surgical approachFocused ultrasoundFibroid volumeMyoma volumeArtery embolizationMenstrual bleedingCurrent management strategiesGnRH antagonistEchographic guidanceSurgical interventionFibroidsInfertilityMedical treatmentUterineWomenOptimal dosageSource of controversyFibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) – protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids
Al-Hendy A, Segars J, Taylor H, González F, Siblini H, Zamah M, Alkelani H, Singh B, Flores V, Christman G, Johnson J, Huang H, Zhang H. Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) – protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids. BMJ Open 2024, 14: e078989. PMID: 38216200, PMCID: PMC10806662, DOI: 10.1136/bmjopen-2023-078989.Peer-Reviewed Original ResearchConceptsUnexplained infertilityIntrauterine inseminationInstitutional review boardCumulative live birth rateUterine fibroidsLive birth rateCause of infertilityFood and Drug AdminstrationGonadotropin hormone-releasing hormoneGreen tea extractDouble-blind clinical trialNon-surgical treatment optionsTimed intrauterine inseminationUterine fibroid sizeOvarian stimulationQuality of Life Questionnaire scoresHormone-releasing hormoneLocal institutional review boardInfertility treatmentNational Institute of Child HealthInstitute of Child HealthMiscarriage rateBirth rateReproductive-age womenEndometrial quality
2023
Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women
Siblini H, Al-Hendy A, Segars J, González F, Taylor H, Singh B, Flaminia A, Flores V, Christman G, Huang H, Johnson J, Zhang H. Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women. Nutrients 2023, 15: 320. PMID: 36678191, PMCID: PMC9861948, DOI: 10.3390/nu15020320.Peer-Reviewed Original ResearchConceptsReproductive-aged womenLiver function testsUterine fibroidsUnexplained infertilityClomiphene citrateSerum liver function testsEpigallocatechin gallateSigns of drugSerum folate levelsGreen tea catechinsHepatic safetyPremenopausal womenProspective cohortDaily doseLiver injuryFunction testsTreatment armsLiver toxicityClinical studiesCommon causeFolate levelsEarly safety assessmentInterim analysisNormal rangeUse of EGCG
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 setPost-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
EPIGALLOCATECHIN GALLATE (EGCG) FOR TREATMENT OF UNEXPLAINED INFERTILITY ASSOCIATED WITH UTERINE FIBROIDS (PRE-FRIEND TRIAL): EARLY SAFETY ASSESSMENT
Siblini H, Al-Hendy A, Segars J, Singh B, Taylor H, Flores V, González F, Christman G, Johnson J, Huang H, Zhang H. EPIGALLOCATECHIN GALLATE (EGCG) FOR TREATMENT OF UNEXPLAINED INFERTILITY ASSOCIATED WITH UTERINE FIBROIDS (PRE-FRIEND TRIAL): EARLY SAFETY ASSESSMENT. Fertility And Sterility 2021, 116: e318-e319. DOI: 10.1016/j.fertnstert.2021.07.857.Peer-Reviewed Original ResearchO-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
166 Efficacy and Safety of Elagolix in a Subgroup of Women with Uterine Fibroids and Adenomyosis: Results from a Phase 2 Trial
Taylor H, Bedaiwy M, Lukes A, Chwalisz K, Owens C, Bradley L. 166 Efficacy and Safety of Elagolix in a Subgroup of Women with Uterine Fibroids and Adenomyosis: Results from a Phase 2 Trial. Journal Of Minimally Invasive Gynecology 2018, 25: s86-s87. DOI: 10.1016/j.jmig.2018.09.175.Peer-Reviewed Original Research741 Patient Experience and Clinical Presentation of US Women with Uterine Fibroids: Results from the First 200 Women Enrolled in a National Real-World Study
Taylor H, Liu J, Al-Hendy A, Jackson-Bey T, Bradley L, Moon K, Kerolous M. 741 Patient Experience and Clinical Presentation of US Women with Uterine Fibroids: Results from the First 200 Women Enrolled in a National Real-World Study. Journal Of Minimally Invasive Gynecology 2018, 25: s281-s282. DOI: 10.1016/j.jmig.2018.09.754.Peer-Reviewed Original ResearchEfficacy and safety of elagolix in a subgroup of women with uterine fibroids and adenomyosis: results from a phase 2 trial
Taylor H, Bedaiwy M, Lukes A, Chwalisz K, Owens C, Bradley L. Efficacy and safety of elagolix in a subgroup of women with uterine fibroids and adenomyosis: results from a phase 2 trial. Fertility And Sterility 2018, 110: e61. DOI: 10.1016/j.fertnstert.2018.07.186.Peer-Reviewed Original Research
2017
Current and Emerging Medical Treatments for Uterine Fibroids
Chwalisz K, Taylor H. Current and Emerging Medical Treatments for Uterine Fibroids. Seminars In Reproductive Medicine 2017, 35: 510-522. PMID: 29100239, DOI: 10.1055/s-0037-1606302.Peer-Reviewed Original ResearchMeSH KeywordsCombined Modality TherapyCost of IllnessDrug ApprovalDrugs, InvestigationalEvidence-Based MedicineFemaleGonadotropin-Releasing HormoneHormone AntagonistsHumansLeiomyomaLeiomyomatosisMenorrhagiaQuality of LifeReceptors, ProgesteroneUnited StatesUnited States Food and Drug AdministrationUterine NeoplasmsConceptsUterine fibroidsMedical therapyMedical treatmentOral gonadotropin-releasing hormone antagonistLong-term medical therapyGonadotropin-releasing hormone antagonistCommon uterine neoplasmPressure-related symptomsHeavy menstrual bleedingProgesterone receptor modulatorsRandomized clinical trialsSymptomatic uterine fibroidsUnited States FoodMenstrual bleedingUterine neoplasmsSymptom managementSurgical interventionHormone antagonistClinical trialsReceptor modulatorsMedical optionsEffective treatmentClinical developmentFibroidsDrug Administration
2014
Uterine Fibroids: Clinical Manifestations and Contemporary Management
Doherty L, Mutlu L, Sinclair D, Taylor H. Uterine Fibroids: Clinical Manifestations and Contemporary Management. Reproductive Sciences 2014, 21: 1067-1092. PMID: 24819877, DOI: 10.1177/1933719114533728.Peer-Reviewed Original ResearchConceptsMedical therapyUterine fibroidsGrowth factorAbnormal uterine bleedingHeavy menstrual bleedingInterventional radiological proceduresEndometrial effectsUterine bleedingMenstrual bleedingMedical managementSurgical managementCommon lesionsCurrent armamentariumFibroid treatmentClinical trialsEffective treatmentFibroidsRadiological proceduresDrug AdministrationFibroid cellsNovel therapeuticsAbnormal regulationTherapyFibroid biologyMolecular changes
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