Trial record 4 of 68 for:    "Sclerosis" AND (woman OR women OR female)

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00127075
First received: August 4, 2005
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients who remain relapse-free during the 12-week period after delivery [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Rate of relapses, percentage of patients who remain relapse-free during the 24-week period after delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of relapses, percentage of patients who remain relapse-free during the 12- to 24-week period after delivery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127075

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00127075     History of Changes
Other Study ID Numbers: 2004.363
Study First Received: August 4, 2005
Last Updated: December 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Sclerosis
Contraceptive Agents, Female
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Megestrol
Progestins
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 17, 2014