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

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.

The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.

The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S. Andrea Hospital
• Treatments: Ethinyl Estradiol; Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Female patients

• Clinically definite relapsing-remitting MS according to the McDonald criteria

• Age between 18-40 y.o.

• EDSS from 0 to 4.0, inclusive

Exclusion Criteria:

• History of migraine or thromboembolic events

• Reproductive system disorders

• Pregnancy or suspension of pregnancy within 12 months prior to randomisation

• Prior use of estroprogestins within the last 3 months prior to randomisation

• Prior use of immunosuppressive drugs within the last 12 months prior to randomisation

• Prior use of immunomodulating drugs within the last 6 months prior to randomisation

• Prior use of corticosteroids within the last 3 months prior to randomisation

• Have clinical relapse 30 days prior to randomisation