Status:
UNKNOWN
POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Multiple Sclerosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chr...
Eligibility Criteria
Inclusion
- MS according to MacDonald criteria (including clinically isolated syndromes fulfilling magnetic resonance imaging \[MRI\] criteria for MS diagnosis)
- Relapsing-remitting or secondary progressive MS
- Expanded disability status scale (EDSS) ≤ 6.0
- Pregnancy ≤ 36 weeks of amenorrhea
Exclusion
- Age \< 18 years
- Clinical isolated syndrome not fulfilling MacDonald criteria for MS
- Primary progressive MS
- Possible MS or no MS according to MacDonald criteria
- Ongoing or previous myocardial infarction, stroke or venous thromboembolism
- Ongoing or previous breast cancer, or cancer of the uterus
- Severe liver disorder
- Undiagnosed genital bleeding
- Hypersensitivity to one of the study treatments
- Desire for lactation
- Desire for an MS disease-modifying treatment in the 24 weeks after delivery
- Women participating in another trial with a drug
- Refusal of non-hormonal contraception in the 12 weeks following delivery
- Consent form not signed
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00127075
Start Date
June 1 2005
End Date
April 1 2012
Last Update
December 30 2011
Active Locations (1)
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1
Hôpital Pierre Wertheimer
Bron, France, 69677