2023
Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women
Siblini H, Al-Hendy A, Segars J, González F, Taylor H, Singh B, Flaminia A, Flores V, Christman G, Huang H, Johnson J, Zhang H. Assessing the Hepatic Safety of Epigallocatechin Gallate (EGCG) in Reproductive-Aged Women. Nutrients 2023, 15: 320. PMID: 36678191, PMCID: PMC9861948, DOI: 10.3390/nu15020320.Peer-Reviewed Original ResearchConceptsReproductive-aged womenLiver function testsUterine fibroidsUnexplained infertilityClomiphene citrateSerum liver function testsEpigallocatechin gallateSigns of drugSerum folate levelsGreen tea catechinsHepatic safetyPremenopausal womenProspective cohortDaily doseLiver injuryFunction testsTreatment armsLiver toxicityClinical studiesCommon causeFolate levelsEarly safety assessmentInterim analysisNormal rangeUse of EGCG
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