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POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127075
Recruitment Status : Unknown
Verified December 2011 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2005
Last Update Posted : December 30, 2011
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery.

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: nomegestrol acetate Drug: estradiol Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
Study Start Date : June 2005
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: NOMA + estradiol
Oral NOMA (LUTENYL® 10 mg/day) combined with transdermal Estradiol (DERMESTRIL SEPTEM® 75 mcg, once a week),
Drug: nomegestrol acetate
10 mg/day

Drug: estradiol
75 mcg, once a week

Placebo Comparator: placebo
Matching placebo treatments
Drug: placebo
matching placebo treatments

Primary Outcome Measures :
  1. To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients who remain relapse-free during the 12-week period after delivery [ Time Frame: 12 weeks ]
  2. Rate of relapses, percentage of patients who remain relapse-free during the 24-week period after delivery [ Time Frame: 24 weeks ]
  3. Rate of relapses, percentage of patients who remain relapse-free during the 12- to 24-week period after delivery [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127075

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Hôpital Pierre Wertheimer
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Christian Confavreux, MD Hospices Civils de Lyon
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon Identifier: NCT00127075    
Other Study ID Numbers: 2004.363
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011
Keywords provided by Hospices Civils de Lyon:
Multiple sclerosis. Relapses. Post partum. Pregnancy. Delivery. Hormones. Progesterone. Estradiol. Clinical trial. Prevention.
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs