POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiolin Multiple sclerosis - POPART`MUS

• Conditions: Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2006-005460-30-IT
• Lead Sponsor: OSPEDALI CIVILI DI LIONE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

- Multiple sclerosis according to Mac Donald criteria (including clinically syndromes fulfilling MRI
criteria for MS diagnosis)
- Relapses-remitting or Secondary Progressive MS
- EDSS ≤ 6.0
- Pregnancy ≤ 36 weeks of amenorrhea
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age < 18 years
- Clinical Isolated Syndrome not fulfilling MacDonald?s criteria
- Primary progressive MS
- Possible MS or no MS according to Mc Donald?s criteria
- On going or previous myocardial infection, stroke or venous thrombo-embolism
- On going or previous breast cancer, or cancer of the uterus
- Severe liver disorder
- Undiagnosed genital bleeding
- Hypersensitivity to one of the study treatment
- Desire for lactation
- Desire for a MS disease-modifying treatment in the 24 weeks after delivery
- Woman participating to another trial with a drug
- Refusal of non-hormonal contraception in the 12 weeks following delivery
- Consent form not signed

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified