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

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

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Estradiol*
  • Female
  • Humans
  • Megestrol
  • Multiple Sclerosis* / drug therapy
  • Norpregnadienes
  • Postpartum Period
  • Pregnancy
  • Recurrence

Substances

  • Norpregnadienes
  • Estradiol
  • nomegestrol acetate
  • Megestrol