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
2018
Long-Term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-Associated Pain [11OP]
Surrey E, Taylor H, Duan W, Peloso P, Schwefel B, Chwalisz K. Long-Term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-Associated Pain [11OP]. Obstetrics And Gynecology 2018, 131: 4s. DOI: 10.1097/01.aog.0000533299.54528.7c.Peer-Reviewed Original ResearchNon-menstrual pelvic painEndometriosis-associated painBone mineral densityAdverse eventsPivotal studiesElagolix treatmentLumbar spine BMD Z-scoreExtension studyNon-peptide GnRH antagonistsSevere endometriosis-associated painSpine BMD Z-scoreEfficacy of elagolixCommon adverse eventsPhase 3 studyBMD Z-scoresNew safety concernsLong-term safetyDose-dependent decreaseDyspareunia scoresEndometrial thicknessPelvic painHot flushesGnRH antagonistDose groupMineral density
2017
61 Long-Term Safety and Efficacy of Elagolix Treatment in Women with Endometriosis-Associated Pain: Primary Results From Two Phase 3 Extension Studies
Surrey E, Taylor H, Giudice L, Singh S, Abrao M, Lessey B, Duan W, Peloso P, Schwefel B, Chwalisz K. 61 Long-Term Safety and Efficacy of Elagolix Treatment in Women with Endometriosis-Associated Pain: Primary Results From Two Phase 3 Extension Studies. Journal Of Minimally Invasive Gynecology 2017, 24: s44-s45. DOI: 10.1016/j.jmig.2017.08.078.Peer-Reviewed Original ResearchLong-term safety and efficacy of elagolix treatment in women with endometriosis-associated pain: primary results from two phase 3 extension studies
Surrey E, Taylor H, Giudice L, Singh S, Abrao M, Lessey B, Duan W, Peloso P, Schwefel B, Chwalisz K. Long-term safety and efficacy of elagolix treatment in women with endometriosis-associated pain: primary results from two phase 3 extension studies. Fertility And Sterility 2017, 108: e95-e96. DOI: 10.1016/j.fertnstert.2017.07.293.Peer-Reviewed Original Research
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