Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study
Sandra Vukusic, Iuliana Ionescu, Catherine Cornu, Nadine Bossard, Françoise Durand‐Dubief, François Cotton, Luca Durelli, Romain Marignier, Laurence Gignoux, David Laplaud, Thibault Moreau, Pierre Clavelou, de Sèze, Marc Debouverie, David Brassat, Jean Pelletier, Christine Lebrun‐Frénay, Emmanuelle Le Page, Giovanni Castelnovo, Éric Berger, Patrick Hautecœur, Olivier Heinzlef, María Trojano, Francesco Patti, Étienne-Émile Baulieu, Laurent Remontet, Martine El‐Etr
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.