Your browser doesn't support javascript.
loading
Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study.
Vukusic, Sandra; Ionescu, Iuliana; Cornu, Catherine; Bossard, Nadine; Durand-Dubief, Françoise; Cotton, François; Durelli, Luca; Marignier, Romain; Gignoux, Laurence; Laplaud, David-Axel; Moreau, Thibault; Clavelou, Pierre; De Seze, Jérôme; Debouverie, Marc; Brassat, David; Pelletier, Jean; Lebrun-Frenay, Christine; Le Page, Emmanuelle; Castelnovo, Giovanni; Berger, Eric; Hautecoeur, Patrick; Heinzlef, Olivier; Trojano, Maria; Patti, Francesco; Baulieu, Etienne-Emile; Remontet, Laurent; El-Etr, Martine.
Afiliação
  • Vukusic S; Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/Centre des Neurosciences de Lyon, INSERM 1028 et CNRS UMR5292, O
  • Ionescu I; Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France.
  • Cornu C; Centre d'Investigation Clinique INSERM1407, Hospices Civils de Lyon, Lyon, France/Service de Pharmaco-toxicologie, Lyon, France/UMR5558, Claude Bernard University, Lyon, France.
  • Bossard N; Hospices Civils de Lyon, Pôle Santé Publique, Service de Biostatistique-Bioinformatique, Lyon, France/Université de Lyon, Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne, France.
  • Durand-Dubief F; Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/CREATIS, UMR 5220 CNRS & U1044 Inserm, Université Claude Ber
  • Cotton F; CREATIS, UMR 5220 CNRS & U1044 Inserm, Université Claude Bernard Lyon1, Université de Lyon, Villeurbanne, France/Service de Radiologie, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Lyon, France.
  • Durelli L; Clinical and Biological Sciences Department, University of Torino, Turin, Italy.
  • Marignier R; Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/Université Claude Bernard Lyon 1, Villeurbanne, France/Centre de
  • Gignoux L; Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France.
  • Laplaud DA; CHU de Nantes, Service de Neurologie & CIC015 INSERM, Nantes, France, INSERM CR1064, Nantes, France.
  • Moreau T; Department of Neurology, EA4184, University Hospital of Dijon, Dijon, France.
  • Clavelou P; Service de Neurologie, CHU Clermont-Ferrand, Clermont-Ferrand, France/Inserm U1107, Clermont Université, Université d'Auvergne, Neuro-Dol, Clermont-Ferrand, France.
  • De Seze J; Department of Neurology and Clinical Investigation Center, CHU de Strasbourg, INSERM, Strasbourg, France.
  • Debouverie M; EA 4360 Apemac, Lorraine University, Nancy, France/Department of Neurology, Nancy University Hospital, Nancy, France.
  • Brassat D; Pôle Neurosciences, CHU Toulouse Purpan, Toulouse, France/INSERM U1043-CNRS UMR 5282, Université Toulouse III, Toulouse, France.
  • Pelletier J; Aix Marseille Univ, APHM, Hôpital de la Timone, Pôle de Neurosciences Cliniques, Service de Neurologie, Marseille, France.
  • Lebrun-Frenay C; CRCSEP Department of Neurology, UR2CA URRIS, Nice, France.
  • Le Page E; Clinical Neuroscience Centre, CIC-P 1414 INSERM, Rennes University Hospital, Rennes, France.
  • Castelnovo G; Department of Neurology, CHU Nîmes, Hôpital Caremeau, Nîmes Cedex, France.
  • Berger E; Department of Neurology, CHU Besançon, Besançon, France.
  • Hautecoeur P; Service de Neurologie, Groupe Hospitalier de l'Institut Catholique de Lille, Lille Cedex, France.
  • Heinzlef O; Neurology Department, Hospital of Poissy-St-Germain en Laye, Paris, France.
  • Trojano M; Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.
  • Patti F; Department of Medical and Surgical Sciences, and Advanced Technologies, GF Ingrassia, Multiple Sclerosis Center, University of Catania, Catania, Italy.
  • Baulieu EE; INSERM U 1195, Le Kremlin-Bicêtre, France.
  • Remontet L; Hospices Civils de Lyon, Pôle Santé Publique, Service de Biostatistique-Bioinformatique, Lyon, France/Université de Lyon, Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne, France.
  • El-Etr M; INSERM U 1195, Le Kremlin-Bicêtre, France.
Mult Scler ; 27(9): 1458-1463, 2021 08.
Article em En | MEDLINE | ID: mdl-33269975
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.
Assuntos
Palavras-chave
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Estradiol / Esclerose Múltipla Tipo de estudo: Clinical_trials Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Estradiol / Esclerose Múltipla Tipo de estudo: Clinical_trials Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2021 Tipo de documento: Article