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
2023
Testosterone-associated blood pressure dysregulation in women with androgen excess polycystic ovary syndrome
Stone T, Yanes Cardozo L, Oluwatade T, Leone C, Burgos M, Okifo F, Pal L, Reckelhoff J, Stachenfeld N. Testosterone-associated blood pressure dysregulation in women with androgen excess polycystic ovary syndrome. AJP Heart And Circulatory Physiology 2023, 325: h232-h243. PMID: 37327000, PMCID: PMC10393337, DOI: 10.1152/ajpheart.00164.2023.Peer-Reviewed Original ResearchConceptsSympathetic nervous system activityBlood pressure dysregulationPolycystic ovary syndromeBody mass indexBaroreflex gainOvary syndromeBlood pressureObese insulin-resistant womenPolycystic ovary syndrome phenotypesRenin-angiotensin system activationSerum angiotensin-converting enzymeGonadotropin-releasing hormone antagonistLower sympathetic nervous system activityLower body negative pressureHeightened cardiovascular riskInsulin-resistant womenSystolic blood pressureBody negative pressureNervous system activityAngiotensin-converting enzymeIR womenCardiovascular riskSerum aldosteroneBaroreflex controlDiastolic BPTestosterone effects on autonomic function in women with androgen excess polycystic ovary syndrome
Stone T, Cardozo L, Oluwatade T, Leone C, Okifo F, Reckelhoff J, Pal L, Stachenfeld N. Testosterone effects on autonomic function in women with androgen excess polycystic ovary syndrome. Physiology 2023, 38: 5729543. DOI: 10.1152/physiol.2023.38.s1.5729543.Peer-Reviewed Original ResearchLower body negative pressureBlood pressureHormone interventionSympathetic baroreflexAutonomic functionSimilar systolic blood pressureGonadotropin-releasing hormone antagonistInsulin-resistant womenDiastolic blood pressurePolycystic ovary syndromeSystolic blood pressureCardiovascular autonomic controlBody negative pressureMSNA activitySerum angiotensinOvarian syndromeOvary syndromeResistant womenBaroreflex sensitivityHormone suppressionSerum aldosteroneAutonomic perturbationsT elevationHormone antagonistElevated androgens
2022
Minimal Stimulation Using Gonadotropin-Releasing Hormone Antagonist is Associated with Higher Live Birth Rates: A National Study of 13,050 Cycles
Hurley E, Sun F, Zhang H, Polotsky A, Rios J. Minimal Stimulation Using Gonadotropin-Releasing Hormone Antagonist is Associated with Higher Live Birth Rates: A National Study of 13,050 Cycles. Women's Health Reports 2022, 3: 957-963. PMID: 36479370, PMCID: PMC9712044, DOI: 10.1089/whr.2022.0080.Peer-Reviewed Original ResearchHigher live birth rateLive birth rateGnRH antagonist useAntagonist useMinimal stimulationRank sum testHormone antagonistBirth rateImproved live birth ratesGonadotropin-releasing hormone antagonistCancelation rateCycle cancelation rateGnRH antagonist suppressionMinimal stimulation IVFTotal gonadotropin dosageDiminished ovarian reserveYears of ageWilcoxon rank sum testChi-square testNumber of embryosGonadotropin dosageOvarian reserveGnRH antagonistAntimullerian hormoneOlder womenO-163 Pathophysiology – what’s new
Taylor H. O-163 Pathophysiology – what’s new. Human Reproduction 2022, 37: deac105.073. DOI: 10.1093/humrep/deac105.073.Peer-Reviewed Original ResearchSystemic diseaseGynecological diseasesOral gonadotropin-releasing hormone antagonistClinical diagnosisLow-dose oral contraceptivesGonadotropin-releasing hormone antagonistEndometrial-like tissueFirst-line medicationAccurate clinical diagnosisFemale reproductive tractOral contraceptivesPrompt treatmentSystemic inflammationGnRH antagonistPain sensitizationProgesterone resistanceSymptomatic womenClinical presentationRetrograde menstruationEndometriosis careHormone antagonistReproductive ageEffective therapyTherapeutic alternativeMood disorders
2021
Androgen Effects on Baroreflex Sensitivity in Women with AE‐PCOS
Stone T, Chiles M, Leone C, Pal L, Stachenfeld N. Androgen Effects on Baroreflex Sensitivity in Women with AE‐PCOS. The FASEB Journal 2021, 35 DOI: 10.1096/fasebj.2021.35.s1.04149.Peer-Reviewed Original ResearchMuscle sympathetic nerve activityLower body negative pressureSympathetic baroreflex sensitivityPolycystic ovary syndromeBaroreflex sensitivityBR controlDiastolic BPHormone suppressionImpaired blood pressure regulationGonadotropin-releasing hormone antagonistOral glucose tolerance testDays of GnRHSympathetic nerve activityInsulin-resistant womenMean arterial pressureVascular resistance changesReproductive-age womenGlucose tolerance testBody negative pressureBlood pressure regulationSuppression of E2Bursts/100 heartbeatsCardiovascular comorbiditiesPCOS phenotypeResistant womenEndometriosis is a chronic systemic disease: clinical challenges and novel innovations
Taylor HS, Kotlyar AM, Flores VA. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. The Lancet 2021, 397: 839-852. PMID: 33640070, DOI: 10.1016/s0140-6736(21)00389-5.Peer-Reviewed Original ResearchConceptsSystemic diseaseGynaecological diseaseOral gonadotropin-releasing hormone antagonistClinical diagnosisLow-dose oral contraceptivesGonadotropin-releasing hormone antagonistEndometrial-like tissueChronic systemic diseaseFirst-line medicationAccurate clinical diagnosisFemale reproductive tractPain sensitisationOral contraceptivesPrompt treatmentSystemic inflammationGnRH antagonistProgesterone resistanceSymptomatic womenClinical presentationRetrograde menstruationEndometriosis careHormone antagonistReproductive ageEffective therapyTherapeutic alternative
2020
Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database
Surrey ES, Soliman AM, Johns B, Vora JB, Taylor HS, Agarwal SK. Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database. ClinicoEconomics And Outcomes Research 2020, 12: 473-479. PMID: 32922052, PMCID: PMC7456657, DOI: 10.2147/ceor.s264905.Peer-Reviewed Original ResearchTreatment 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
Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials
Pokrzywinski RM, Soliman AM, Chen J, Snabes MC, Coyne KS, Surrey ES, Taylor HS. Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials. American Journal Of Obstetrics And Gynecology 2019, 222: 592.e1-592.e10. PMID: 31759891, DOI: 10.1016/j.ajog.2019.11.1255.Peer-Reviewed Original ResearchConceptsEndometriosis Health Profile-30Nonmenstrual pelvic painHealth-related qualityEndometriosis-associated painPelvic painMonth 3Clinical responseClinical respondersPain symptomsMeaningful improvementsEndometriosis-related pain symptomsSevere endometriosis-associated painSevere endometriosis-related painGonadotropin-releasing hormone antagonistPhase III clinical trialsPain reduction scoresPain responder statusSelf-reported bleedingPlacebo-controlled studyEndometriosis-related painSelf-reported painWork productivityReceiver-operating characteristic analysisNumber of symptomsProductivity QuestionnaireBaseline endometriosis-associated pain burden: Data from 1600+ women enrolled in elagolix clinical trials
Leyland N, Estes S, Eichner S, Soliman A, Mai Y, Snabes M, Taylor H, Surrey E. Baseline endometriosis-associated pain burden: Data from 1600+ women enrolled in elagolix clinical trials. Journal Of Endometriosis And Pelvic Pain Disorders 2019, 11: 117-125. DOI: 10.1177/2284026519864232.Peer-Reviewed Original ResearchEndometriosis-associated painNonmenstrual pelvic painPelvic painClinical trialsMean Numeric Rating Scale scoreSevere endometriosis-associated painPlacebo-controlled clinical trialGonadotropin-releasing hormone antagonistNumeric rating scale scoreRescue medication usePhase 3 studyNumeric rating scaleRating Scale scoresScreening phaseBaseline painEndometriosis medicationsPain burdenEndometriosis painMedication useHormone antagonistScreening periodPainScale scoreDaily burdenStudy participants
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
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 AdministrationTreatment 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 flushesO-GYN-MD-126 Primary Efficacy and Safety Results from Two Double-Blind, Randomized, Placebo-Controlled Studies Of Elagolix, an Oral Gonadotropin-Releasing Hormone Antagonist, in Women With Endometriosis-Associated Pain
Singh S, Taylor H, Giudice L, Lessey B, Abrao M, Kotarski J, Duan W, Schwefel B, Thomas J, Chwalisz K. O-GYN-MD-126 Primary Efficacy and Safety Results from Two Double-Blind, Randomized, Placebo-Controlled Studies Of Elagolix, an Oral Gonadotropin-Releasing Hormone Antagonist, in Women With Endometriosis-Associated Pain. Journal Of Obstetrics And Gynaecology Canada 2017, 39: 401. DOI: 10.1016/j.jogc.2017.03.067.Peer-Reviewed Original ResearchGonadotropin-releasing hormone antagonistEndometriosis-associated painPrimary efficacyHormone antagonistSafety resultsPlaceboPainRandomizedElagolixAntagonistWomen
2016
Elagolix, an oral gonadotropin-releasing hormone antagonist, for the management of endometriosis-associated pain: safety and efficacy results from two double-blind, randomized, placebo-controlled studies
Taylor H, Giudice L, Lessey B, Abrao M, Kotarski J, Williams L, Rowan J, Chwalisz K, Duan W, Schwefel B, Thomas J, Jain R. Elagolix, an oral gonadotropin-releasing hormone antagonist, for the management of endometriosis-associated pain: safety and efficacy results from two double-blind, randomized, placebo-controlled studies. Fertility And Sterility 2016, 106: e271. DOI: 10.1016/j.fertnstert.2016.07.780.Peer-Reviewed Original ResearchOral gonadotropin-releasing hormone antagonistGonadotropin-releasing hormone antagonistEndometriosis-associated painHormone antagonistEfficacy resultsPainElagolixAntagonist
2015
Strategies for Controlled Ovarian Stimulation in the Setting of Ovarian Aging
Ata B, Seli E. Strategies for Controlled Ovarian Stimulation in the Setting of Ovarian Aging. Seminars In Reproductive Medicine 2015, 33: 436-448. PMID: 26562286, DOI: 10.1055/s-0035-1567818.Peer-Reviewed Original ResearchConceptsControlled ovarian stimulationOvarian agingOvarian stimulationPossible side effects profileShort GnRH agonist protocolGonadotropin-releasing hormone antagonistGnRH agonist protocolTotal gonadotropin consumptionIU/daySide effect profileCost of medicationsGrowth hormone supplementationHigh-quality evidenceTransdermal testosterone administrationDuration of stimulationQuality of oocytesAppropriate first choiceAgonist protocolCOS protocolsEstradiol primingGonadotropin consumptionGonadotropin dosageEffect profileHormone antagonistHormone supplementation
2013
Androgens influence microvascular dilation in PCOS through ET-A and ET-B receptors
Wenner MM, Taylor HS, Stachenfeld NS. Androgens influence microvascular dilation in PCOS through ET-A and ET-B receptors. AJP Endocrinology And Metabolism 2013, 305: e818-e825. PMID: 23921139, PMCID: PMC3798701, DOI: 10.1152/ajpendo.00343.2013.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromeET-B receptorsMicrovascular dilationHeat-induced vasodilationReceptor inhibitionET-B receptor antagonistGonadotropin-releasing hormone antagonistLaser Doppler flowmetryAndrogen suppressionOvary syndromeVascular dysfunctionHealthy womenT administrationEnhanced vasodilationHormone antagonistReceptor antagonistCutaneous microdialysisDoppler flowmetryTestosterone effectsSubtype receptorsVasodilationDay 8WomenDilationGnRHant
2012
Advances in Treatment Options for Polycystic Ovary Syndrome
Lathief S, Pal L. Advances in Treatment Options for Polycystic Ovary Syndrome. US Endocrinology 2012, 08: 57. DOI: 10.17925/use.2012.08.01.57.Peer-Reviewed Original ResearchManagement of PCOSPolycystic ovary syndromePathophysiology of PCOSClomiphene citrateOvary syndromeGonadotropin-releasing hormone antagonistPCOS-related infertilityOvarian stimulation protocolsFirst-line strategyRisk of diabetesAlternative medical therapiesClinical management paradigmsOvarian drillingAnovulatory infertilityOvulatory infertilityAndrogen excessMenstrual irregularitiesOvulation inductionPCOS symptomsMedical therapyCommon endocrinopathyHormonal contraceptivesMenstrual disordersInsulin sensitizersTherapeutic options
2010
Greater Exercise Sweating in Obese Women with Polycystic Ovary Syndrome Compared with Obese Controls
STACHENFELD NS, YECKEL CW, TAYLOR HS. Greater Exercise Sweating in Obese Women with Polycystic Ovary Syndrome Compared with Obese Controls. Medicine & Science In Sports & Exercise 2010, 42: 1660-1668. PMID: 20195177, PMCID: PMC3109293, DOI: 10.1249/mss.0b013e3181d8cf68.Peer-Reviewed Original ResearchConceptsPolycystic ovary syndromePCOS groupOvary syndromeControl groupGonadotropin-releasing hormone antagonistObese controlsObese womenAge-predicted HRmaxCore temperature thresholdHormone antagonistTestosterone effectsDay 4GnRHantSweat volumeDay 13Total sweat lossHormone conditionsWomenSweatingE2Sweat lossSyndromeEstradiolTestosteroneThermoregulatory responses
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