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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127075
First Posted: August 5, 2005
Last Update Posted: December 30, 2011
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.
Information provided by (Responsible Party):
Hospices Civils de Lyon
August 4, 2005
August 5, 2005
December 30, 2011
June 2005
April 2012   (Final data collection date for primary outcome measure)
To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups [ Time Frame: 12 weeks ]
To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups.
Complete list of historical versions of study NCT00127075 on ClinicalTrials.gov Archive Site
  • Percentage of patients who remain relapse-free during the 12-week period after delivery [ Time Frame: 12 weeks ]
  • Rate of relapses, percentage of patients who remain relapse-free during the 24-week period after delivery [ Time Frame: 24 weeks ]
  • Rate of relapses, percentage of patients who remain relapse-free during the 12- to 24-week period after delivery [ Time Frame: 24 weeks ]
  • Secondary clinical outcomes
  • o Percentage of patients who remain relapse-free during the 12-week period after delivery
  • o Rate of relapses, percentage of patients who remain relapse-free during the 24-week period after delivery
  • o Rate of relapses, percentage of patients who remain relapse-free during the 12- to 24-week period after delivery
Not Provided
Not Provided
 
POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: nomegestrol acetate
    10 mg/day
  • Drug: estradiol
    75 mcg, once a week
  • Drug: placebo
    matching placebo treatments
  • Experimental: NOMA + estradiol
    Oral NOMA (LUTENYL® 10 mg/day) combined with transdermal Estradiol (DERMESTRIL SEPTEM® 75 mcg, once a week),
    Interventions:
    • Drug: nomegestrol acetate
    • Drug: estradiol
  • Placebo Comparator: placebo
    Matching placebo treatments
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00127075
2004.363
Yes
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Christian Confavreux, MD Hospices Civils de Lyon
Hospices Civils de Lyon
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP