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Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study

Sandra Vukusic 1, 2, 3 Iuliana Ionescu 3, 2 Catherine Cornu 4, 5 Nadine Bossard 4, 6 Françoise Durand-Dubief 7, 2 François Cotton 7, 8 Luca Durelli 9 Romain Marignier 1, 2 Laurence Gignoux 3, 2 David-Axel Laplaud 10, 11 Thibault Moreau 12 Pierre Clavelou 13 Jérôme de Seze 14 Marc Debouverie 15 David Brassat 16, 17 Jean Pelletier 18 Christine Lebrun-Frenay 19 Emmanuelle Le Page 20, 21 Giovanni Castelnovo 22 Eric Berger 23 Patrick Hautecoeur 24 Olivier Heinzlef 25 Maria Trojano 26 Francesco Patti 27 Etienne-Emile Baulieu 28 Laurent Remontet 4, 6 Martine El-Etr 28
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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https://hal.archives-ouvertes.fr/hal-03101890
Contributor : Laurent Jonchère <>
Submitted on : Thursday, January 7, 2021 - 12:21:59 PM
Last modification on : Tuesday, July 20, 2021 - 5:20:04 PM

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Sandra Vukusic, Iuliana Ionescu, Catherine Cornu, Nadine Bossard, Françoise Durand-Dubief, et al.. Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study. Multiple Sclerosis Journal, SAGE Publications, 2020, pp.135245852097821. ⟨10.1177/1352458520978218⟩. ⟨hal-03101890⟩

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