POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
NCT ID: NCT00127075
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2005-06-30
2012-04-30
Brief Summary
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It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART'MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NOMA + estradiol
Oral NOMA (LUTENYL® 10 mg/day) combined with transdermal Estradiol (DERMESTRIL SEPTEM® 75 mcg, once a week),
nomegestrol acetate
10 mg/day
estradiol
75 mcg, once a week
placebo
Matching placebo treatments
placebo
matching placebo treatments
Interventions
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nomegestrol acetate
10 mg/day
estradiol
75 mcg, once a week
placebo
matching placebo treatments
Eligibility Criteria
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Inclusion Criteria
* Relapsing-remitting or secondary progressive MS
* Expanded disability status scale (EDSS) ≤ 6.0
* Pregnancy ≤ 36 weeks of amenorrhea
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Christian Confavreux, MD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hôpital Pierre Wertheimer
Bron, , France
Countries
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References
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Confavreux C, Hutchinson M, Hours MM, Cortinovis-Tourniaire P, Moreau T. Rate of pregnancy-related relapse in multiple sclerosis. Pregnancy in Multiple Sclerosis Group. N Engl J Med. 1998 Jul 30;339(5):285-91. doi: 10.1056/NEJM199807303390501.
Confavreux C, Hutchinson M, Hours M, Cortinovis-Tourniaire P, Grimaud J, Moreau T. [Multiple sclerosis and pregnancy: clinical issues]. Rev Neurol (Paris). 1999 Mar;155(3):186-91. French.
Vukusic S, Hutchinson M, Hours M, Moreau T, Cortinovis-Tourniaire P, Adeleine P, Confavreux C; Pregnancy In Multiple Sclerosis Group. Pregnancy and multiple sclerosis (the PRIMS study): clinical predictors of post-partum relapse. Brain. 2004 Jun;127(Pt 6):1353-60. doi: 10.1093/brain/awh152. Epub 2004 May 6.
Vukusic S, Ionescu I, El-Etr M, Schumacher M, Baulieu EE, Cornu C, Confavreux C; Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis Study Group. The Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis (POPART'MUS) trial: rationale, objectives and state of advancement. J Neurol Sci. 2009 Nov 15;286(1-2):114-8. doi: 10.1016/j.jns.2009.08.056. Epub 2009 Sep 15.
Related Links
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European database for multiple sclerosis
Other Identifiers
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2004.363
Identifier Type: -
Identifier Source: org_study_id