POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiol in Multiple sclerosis - POPART`MUS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005460-30-IT

Enrollment

300

Registered

2008-10-27

Start date

2007-05-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis

Interventions

Trade Name: DEMESTRIL SEPTEM Pharmaceutical Form: Transdermal patch INN or Proposed INN: Estradiol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .075- Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Multiple sclerosis according to Mac Donald criteria (including clinically syndromes fulfilling MRI criteria for MS diagnosis) - Relapses-remitting or Secondary Progressive MS - EDSS &#8804; 6.0 - Pregnancy &#8804; 36 weeks of amenorrhea Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Age < 18 years - Clinical Isolated Syndrome not fulfilling MacDonald?s criteria - Primary progressive MS - Possible MS or no MS according to Mc Donald?s criteria - On going or previous myocardial infection, stroke or venous thrombo-embolism - On going or previous breast cancer, or cancer of the uterus - Severe liver disorder - Undiagnosed genital bleeding - Hypersensitivity to one of the study treatment - Desire for lactation - Desire for a MS disease-modifying treatment in the 24 weeks after delivery - Woman participating to another trial with a drug - Refusal of non-hormonal contraception in the 12 weeks following delivery - Consent form not signed

Design outcomes

Primary

Measure	Time frame
Main Objective: to test the hypothesis that a progestin given soon after delivery together with low doses estradiol prevent relapses in the first post partum trimester in parturing women with multiple sclerosis;Secondary Objective: to assess the effect of this combination on other clinical and MRI parameters;Primary end point(s): The primary endpoint is to compare the rate of relapses during the dirst 12 weeks after delivery, between the treated and placebo groups	—

Measure

Time frame

Main Objective: to test the hypothesis that a progestin given soon after delivery together with low doses estradiol prevent relapses in the first post partum trimester in parturing women with multiple sclerosis;Secondary Objective: to assess the effect of this combination on other clinical and MRI parameters;Primary end point(s): The primary endpoint is to compare the rate of relapses during the dirst 12 weeks after delivery, between the treated and placebo groups

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026