40
Participants
Start Date
October 29, 2019
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection
Active treatment (Nebido® Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
Placebo 4 mL Solution for Injection
Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)
MRI
Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)
Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities
BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)
Assessment of disability
EDSS (Baseline, week 30 and 66)
RECRUITING
CHU de Besançon, Besançon
RECRUITING
CHU de Rennes/Pontchaillou, Rennes
RECRUITING
CHU Nancy, Nancy
RECRUITING
CHRU de Strasbourg, Strasbourg
RECRUITING
Hôpital Pitié-Salpêtrière, Paris
Collaborators (2)
Bayer
INDUSTRY
Fédération Hospitalo-Universitaire NEUROGENYCS
UNKNOWN
Grünenthal GmbH
INDUSTRY
University Hospital, Strasbourg, France
OTHER