2025
Quinagolide 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
O-021 Magnetic Resonance Imaging (MRI) evaluation of Quinagolide Vaginal Ring (QVR) treatment on endometrioma, Deep Infiltrating Endometriosis (DIE), and adenomyosis lesion characteristics: QLARITY trial results
Pellicer A, Taylor H, Alberich-Bayaari Á, Liu Y, Gamborg M, Barletta K, Heiser P, Pinton P, Bagger Y. O-021 Magnetic Resonance Imaging (MRI) evaluation of Quinagolide Vaginal Ring (QVR) treatment on endometrioma, Deep Infiltrating Endometriosis (DIE), and adenomyosis lesion characteristics: QLARITY trial results. Human Reproduction 2024, 39: deae108.021. DOI: 10.1093/humrep/deae108.021.Peer-Reviewed Original ResearchDeep infiltrating endometriosisMagnetic resonance imagingVaginal ringLesion regressionImaging biomarkersLesion sizeAdverse eventsFractional volume of extravascular extracellular spaceAssociated with chronic pelvic painPlacebo-controlled phase 2 trialAdvanced stages of endometriosisVolume of extravascular extracellular spaceDopamine D2 receptor agonistLesion burdenTreatment efficacyGroup compared to placeboSeverity of adverse eventsDIE groupPlacebo vaginal ringChronic pelvic painD2 receptor agonistLesion typePhase 2 trialStages of endometriosisCompared to placebo
2023
Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set
Cooper N, Rivas C, Munro M, Critchley H, Clark T, Matteson K, Papadantonaki R, Yorke S, Tan A, Rodriguez M, Bongers M, Al‐Hendy A, Bahamondes L, Connolly A, Farquhar C, Valbrun T, Hickey M, Taylor H, Toub D, Vannuccini S, Iliodromiti S, Khan K. Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set. BJOG An International Journal Of Obstetrics & Gynaecology 2023, 130: 1337-1345. PMID: 37055716, DOI: 10.1111/1471-0528.17473.Peer-Reviewed Original ResearchConceptsHeavy menstrual bleedingCore outcomeFinal COSMenstrual bleedingClinical trialsConsensus meetingSystematic reviewSeverity of dysmenorrhoeaNumber of patientsPotential core outcomesInternational Consensus MeetingQuality of lifeDelphi surveyTwo-round Delphi surveyAdverse eventsBlood lossHemoglobin levelsFuture trialsGynecology DepartmentCOMET InitiativePatient satisfactionClinical guidelinesResource settingsOnline international surveyFurther treatment
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 events
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
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply