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 treatment
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
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