This trial is active, not recruiting.

Condition multiple sclerosis
Treatments nomegestrol acetate, estradiol, placebo
Phase phase 3
Sponsor Hospices Civils de Lyon
Start date June 2005
End date April 2012
Trial size 300 participants
Trial identifier NCT00127075, 2004.363


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Oral NOMA (LUTENYL® 10 mg/day) combined with transdermal Estradiol (DERMESTRIL SEPTEM® 75 mcg, once a week),
nomegestrol acetate
10 mg/day
75 mcg, once a week
(Placebo Comparator)
Matching placebo treatments
matching placebo treatments

Primary Outcomes

To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups
time frame: 12 weeks

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
Principal investigator Christian Confavreux, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.