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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
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: August 4, 2005
Last updated: December 28, 2011
Last verified: December 2011

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 Intervention Phase
Multiple Sclerosis Drug: nomegestrol acetate Drug: estradiol Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: June 2005
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
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Please refer to this study by its identifier: NCT00127075

Hôpital Pierre Wertheimer
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Christian Confavreux, MD Hospices Civils de Lyon
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon Identifier: NCT00127075     History of Changes
Other Study ID Numbers: 2004.363
Study First Received: August 4, 2005
Last Updated: December 28, 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:
Multiple Sclerosis
Contraceptive Agents, Female
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents processed this record on September 21, 2017