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Randomized Controlled Trial
. 2021 Aug;27(9):1458-1463.
doi: 10.1177/1352458520978218. Epub 2020 Dec 3.

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

Sandra Vukusic  1 , Iuliana Ionescu  2 , Catherine Cornu  3 , Nadine Bossard  4 , Françoise Durand-Dubief  5 , François Cotton  6 , Luca Durelli  7 , Romain Marignier  8 , Laurence Gignoux  2 , David-Axel Laplaud  9 , Thibault Moreau  10 , Pierre Clavelou  11 , Jérôme De Seze  12 , Marc Debouverie  13 , David Brassat  14 , Jean Pelletier  15 , Christine Lebrun-Frenay  16 , Emmanuelle Le Page  17 , Giovanni Castelnovo  18 , Eric Berger  19 , Patrick Hautecoeur  20 , Olivier Heinzlef  21 , Maria Trojano  22 , Francesco Patti  23 , Etienne-Emile Baulieu  24 , Laurent Remontet  4 , Martine El-Etr  24
Affiliations
Randomized Controlled Trial

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

Sandra Vukusic et al. Mult Scler. 2021 Aug.

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.

Keywords: Multiple sclerosis; estradiol; post-partum; progesterone; relapses; sex hormones.

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