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
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
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