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 treatmentTwo-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
Post-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
2020
Treatment 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
2018
Long-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
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