Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nebido Testosterone Undecanoate · 1 trial · 1 indication
The primary endpoint is a binary criterion comparing the success rate in each treatment group, defined by thalamic atrophy lower than 0.5% and modification in transverse diffusivity of lesions lower than 0.5% per year compared between baseline and week 66 in each group.
| Arm | Type | Description |
|---|---|---|
| Testosterone treatment (Nebido®) | EXPERIMENTAL | "Treatment/Nebido®" arm: in this experimental arm, each patient will be injected intramuscularly with 1000 mg / 4 ml of testosterone undecanoate (Nebido®). Treatment will be injected at baseline, week 6, 18, 30, 42 and 54 |
| Placebo | PLACEBO_COMPARATOR | "Placebo" arm: In this arm, each patient will be injected intramuscularly with 4 ml of placebo solution. Placebo will be injected at baseline, week 6, 18, 30, 42 and 54 |
| Name | Type | Description |
|---|---|---|
| Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection | DRUG | 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 | DRUG | Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54) |
| MRI | PROCEDURE | 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 | BEHAVIORAL | BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66) |
| Assessment of disability | BEHAVIORAL | EDSS (Baseline, week 30 and 66) |
Inclusion Criteria: * Man between 18 and 55 years * Patient affiliated to a social health insurance plan * Patient able to understand the objectives and risks related to the research and able to comply with the requirements of the protocol throughout the duration of the study * Patient having been ...