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 valuesQuinagolide 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
2021
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
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
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