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- W4221016951 abstract "IntroductionMost women develop MS before menopause. Menopausal hot flashes can worsen MS symptoms, and could be relieved with hormone therapy. Our objective was to evaluate feasibility, tolerability and symptom response of Duavee® (bazedoxifene + conjugated estrogen) in a Phase Ib/IIa double-blind randomized controlled clinical trial.MethodsWe randomized 24 peri/postmenopausal women with MS and symptomatic hot flashes 1:1 to Duavee® versus placebo. Evaluations occurred at baseline and 2 months.ResultsGroups were balanced for age (mean 51.2 ± 3.6 years), EDSS [median 3 (IQR:2.5, 4.5)], and MS duration. 21/24 participants completed the study. Feasibility: Enrollment was protracted (34 months), partially due to concerns about hormone therapy safety. Tolerability: treatment group participants reported greater satisfaction and fewer missed doses; one participant (placebo) developed new MRI lesions; liver function testing remained normal for all patients. Symptoms: Hot Flash Related Daily Interference scale at 2 months was lower in treatment vs. placebo group [median (IQR) of 4 (0.5, 14) vs. 9 (0, 33)]. Between-group differences were not statistically significant.ConclusionDespite perceived benefits in MS, estrogens have perceived risks that represent a hurdle to enrollment. With appropriate education and screening of participants, the favorable study retention (87%) and treatment satisfaction observed in the current study support the feasibility of a longer, powered trial to evaluate whether a proven treatment for menopausal symptoms, Duavee®, could also improve MS-related function in menopausal women with MS." @default.
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- W4221016951 date "2022-05-01" @default.
- W4221016951 modified "2023-10-17" @default.
- W4221016951 title "A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial" @default.
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- W4221016951 doi "https://doi.org/10.1016/j.msard.2022.103747" @default.
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