Abstract
Background:
Sex steroids could explain the course of multiple sclerosis (MS) in pregnancy.
Objective:
To compare the annualized relapse rate (ARR) 12 weeks post-partum in women treated with nomegestrol acetate (NOMAc) and 17-beta-estradiol (E2) versus placebo.
Methods:
POPARTMUS is a randomized, proof-of-concept trial in women with MS, receiving oral NOMAc 10 mg/day and transdermal estradiol 75 µg/week, or placebo.
Results:
Recruitment was stopped prematurely due to slow inclusions (n = 202). No treatment effect was observed on ARR after 12 weeks (sex steroids = 0.90 (0.58–1.39), placebo = 0.97 (0.63–1.50) (p = 0.79)).
Conclusion:
POPARTMUS failed showing efficacy of a NOMAc–E2 combination in preventing post-partum relapses.
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