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.

中文翻译：

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口服醋酸诺美孕酮和透皮 17-β-雌二醇预防多发性硬化症产后复发：POPARTMUS 研究

背景 性类固醇可以解释妊娠期多发性硬化症 (MS) 的病程。目的 比较醋酸诺美孕酮 (NOMAc) 和 17-β-雌二醇 (E2) 与安慰剂治疗的女性产后 12 周的年复发率 (ARR)。方法 POPARTMUS 是一项随机、概念验证试验，针对 MS 女性，接受口服 NOMAc 10 毫克/天和经皮雌二醇 75 微克/周，或安慰剂。结果 由于内含物缓慢（n = 202），招募过早停止。12 周后未观察到对 ARR 的治疗效果（性类固醇 = 0.90 (0.58-1.39)，安慰剂 = 0.97 (0.63-1.50) (p = 0.79)）。结论 POPARTMUS 未能显示 NOMAc-E2 组合在预防产后复发方面的功效。