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 placeboUterine fibroid–related infertility: mechanisms and management
Donnez J, Taylor H, Marcellin L, Dolmans M. Uterine fibroid–related infertility: mechanisms and management. Fertility And Sterility 2024, 122: 31-39. PMID: 38453041, DOI: 10.1016/j.fertnstert.2024.02.049.Peer-Reviewed Original ResearchUterine artery embolizationUterine fibroidsAssociation of fibroidsAdd-back therapyHeavy menstrual bleedingBaseline to weekOral GnRH antagonistPresence of fibroidsNon-surgical approachFocused ultrasoundFibroid volumeMyoma volumeArtery embolizationMenstrual bleedingCurrent management strategiesGnRH antagonistEchographic guidanceSurgical interventionFibroidsInfertilityMedical treatmentUterineWomenOptimal dosageSource of controversy
2022
Linzagolix With and Without Hormonal Add-Back Therapy for the Treatment of Symptomatic Uterine Fibroids: Two Randomized, Placebo-Controlled, Phase 3 Trials
Donnez J, Taylor H, Stewart E, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland J, 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 Randomized, Placebo-Controlled, Phase 3 Trials. Obstetrical & Gynecological Survey 2022, 77: 741-742. DOI: 10.1097/ogx.0000000000001113.Peer-Reviewed Original Research