2024
Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial
Taylor H, Dong L, Haikonen J, Oppelt P, Tamussino K, Wenzl R, Faustmann T, Groettrup-Wolfers E, Ren X, Seitz C. Vilaprisan for the treatment of symptomatic endometriosis: results from a terminated phase 2b randomized controlled trial. F&S Reports 2024, 5: 189-196. PMID: 38983729, PMCID: PMC11228778, DOI: 10.1016/j.xfre.2024.03.002.Peer-Reviewed Original ResearchPelvic painSymptomatic endometriosisTreatment of symptomatic endometriosisEndometriosis-associated pelvic painBaseline to month 3Use of pain medicationAverage pain scoreMonths of treatmentPhase 2b randomized controlled trialAssess treatment effectsOutcome measures Primary outcomesPlacebo recipientsRandomized controlled trialsPain scoresMonth 3Pain medicationIncreased painVilaprisanPlaceboPrimary outcomeEndometriosisToxicity findingsIntervention participantsClinical relevanceBleeding intensity
2022
O-306 LINZAGOLIX FOR ENDOMETRIOSIS-ASSOCIATED PAIN: SAFETY RESULTS FROM EDELWEISS 3, A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Donnez J, Taylor H, Gemzell-Danielsson K, Catherino W, Bestel E, Gotteland J, Humberstone A, Moore L, Garner E. O-306 LINZAGOLIX FOR ENDOMETRIOSIS-ASSOCIATED PAIN: SAFETY RESULTS FROM EDELWEISS 3, A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL. Human Reproduction 2022, 37: deac105.103. DOI: 10.1093/humrep/deac105.103.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsEndometriosis-associated painSevere endometriosis-associated painBone mineral densityMonths of treatmentSafety resultsPlacebo groupTreatment armsSerious treatment-emergent adverse eventsLumbar spine bone mineral densityZ-scoreLS bone mineral densityMulticenter phase 3 trialSpine bone mineral densityEmergent adverse eventsPhase 3 trialActive treatment armsReproductive-aged womenGnRH receptor antagonistTRIAL REGISTRATION NUMBERMean percent changePARTICIPANTS/MATERIALSROLE OF CHANCEDose-dependent mannerAdverse events