Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients

Phase 2, randomised, single blind, three arms study. Follow-up of 24 months. The study will include relapsing-remitting multiple sclerosis female patients. Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg). Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis. A complete neurological examination (with EDSS) will be performed at month 0, 6, 12, 18 and 24. MRI examination will be assessed at baseline and at month 12 and 24. In the same day of MRI examination we'll collect blood samples for hormonal analysis (we'll measure sex hormones in the follicular and in the luteal phase of a single menstrual cycle). During the follow-up patients will be evaluated also with: MS-Functional Composite at month 0, 6, 12, 18, 24; neuropsychological evaluation at month 0, 12, 24; Fatigue Severity Scale at month 0, 12, 24; Hamilton Depression Scale at month 0, 12, 24; Quality of Life scale (MSQOL54) at month 0, 12, 24.